Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2026-02-02 @ 5:26 PM
Study NCT ID:
NCT00853632
Status:
COMPLETED
Last Update Posted:
2025-05-14
First Post:
2009-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Switzerland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Aya_Westbrook@edwards.com', 'phone': '949-250-2500', 'title': 'Director of Clinical Affairs', 'organization': 'Edwards Lifesciences'}, 'certainAgreement': {'otherDetails': 'Publication of overall study results which have not been released requires written approval of Sponsor, but presentation of site-specific results can occur subject to review by Sponsor. Manuscripts will be submitted to Sponsor for review 30 days prior to submission of manuscript for publication/presentation. Sponsor may ask for a 60-day delay of submission of manuscripts for publication to protect proprietary information and filing of related patent applications.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Events occurring from baseline through eight years of follow-up post implant.', 'description': 'Adverse event table is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.', 'eventGroups': [{'id': 'EG000', 'title': 'Device - CEP Mitral Valve', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.', 'otherNumAtRisk': 329, 'deathsNumAtRisk': 329, 'otherNumAffected': 206, 'seriousNumAtRisk': 329, 'deathsNumAffected': 88, 'seriousNumAffected': 281}], 'otherEvents': [{'term': 'BLEEDING - MINOR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 22, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ARRHYTHMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 108, 'numAffected': 70}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CARDIAC CONDUCTION DISTURBANCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 42, 'numAffected': 34}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CARDIOVASCULAR - OTHER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 32, 'numAffected': 26}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PLEURAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 45, 'numAffected': 44}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ABNORMAL LAB VALUES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 41, 'numAffected': 26}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ANEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 40, 'numAffected': 36}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'GASTRO-INTESTINAL COMPLICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 30, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HEMATOLOGICAL DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 30, 'numAffected': 27}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 22, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'INFECTION / INFLAMMATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 54, 'numAffected': 35}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'NEUROLOGICAL COMPLICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 24, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'OTHER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 173, 'numAffected': 78}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RENAL COMPLICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 34, 'numAffected': 31}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RESPIRATORY COMPLICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 96, 'numAffected': 62}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 37, 'numAffected': 30}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'BLEEDING - MAJOR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 78, 'numAffected': 60}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BLEEDING - MINOR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 26, 'numAffected': 23}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ANGINA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 19, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AORTIC REGURGITATION (NATIVE)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ARRHYTHMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 149, 'numAffected': 99}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CARDIAC CONDUCTION DISTURBANCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 52, 'numAffected': 52}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CARDIAC FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 108, 'numAffected': 73}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CARDIOVASCULAR - OTHER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 37, 'numAffected': 32}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CARDIOVASCULAR DISSECTION / TEAR / INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ENDOCARDITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'NSVD - INAPPROPRIATE SIZING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'NSVD - PARAVALVULAR LEAK - MAJOR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PLEURAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 57, 'numAffected': 49}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PNEUMOTHORAX / HEMOTHORAX', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PULMONARY EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SVD - OTHER STRUCTURAL VALVE DETERIORATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SVD - STUDY VALVE CALCIFICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SVD - STUDY VALVE WEAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'THROMBOEMBOLISM - NON-CEREBRAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'THROMBOEMBOLISM - STROKE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 20, 'numAffected': 18}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'THROMBOEMBOLISM - TIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'TRICUSPID REGURGITATION (NATIVE)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VALVE THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VASCULAR COMPLICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VENTRICULAR RUPTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ABNORMAL LAB VALUES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ANEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 32, 'numAffected': 31}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BONE FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 32, 'numAffected': 29}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 33, 'numAffected': 28}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CARDIAC ARREST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COAGULOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'DRUG REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'EDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'FEVER - UNKNOWN ORIGIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'GASTRO-INTESTINAL COMPLICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 69, 'numAffected': 53}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HEMATOLOGICAL DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 21, 'numAffected': 19}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HEPATIC COMPLICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'INFECTION / INFLAMMATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 98, 'numAffected': 59}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'METABOLIC COMPLICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'MULTIPLE ORGAN FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'NEUROLOGICAL COMPLICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 20, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'OTHER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 112, 'numAffected': 79}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PSYCHIATRIC COMPLICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RENAL COMPLICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 42, 'numAffected': 36}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RESPIRATORY COMPLICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 133, 'numAffected': 86}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SEPTICEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'STERNAL / THORACIC WOUND COMPLICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SUDDEN DEATH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SUICIDE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VISION DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Subject's Rate of Objective Performance Criteria Per ISO 5840-2005 - Total Number of Late Adverse Events (by Category) Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort", 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device - CEP Mitral Valve', 'description': 'Subjects who received a Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}], 'classes': [{'title': 'Thromboembolism', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}]}]}, {'title': 'All bleeding events', 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000'}]}]}, {'title': 'All paravalvular leak', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'Endocarditis', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Events occurring ≥ 31 days and up through 8 years post-implant', 'description': "A linearized rate percentage is calculated by the following equation: \\[(Total number of late adverse events in each category/total number of late patient years) x 100\\]. Late adverse events are events that occur ≥ 31 days post-implant through each subject's last follow-up visit or contact. Late patient years are calculated by totaling the amount of time the valve is implanted in the patient while participating in the trial and the count begins at ≥ 31 days post-implant through all subject's last follow-up visit or contact.", 'unitOfMeasure': 'Linearized rate percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.'}, {'type': 'PRIMARY', 'title': 'Primary Effectiveness Endpoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device - CEP Mitral Valve', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}], 'classes': [{'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 years post-implant', 'description': 'The primary effectiveness endpoint will be the percentage of subjects in NYHA functional classification I or II at 8 years post-implant.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.'}, {'type': 'SECONDARY', 'title': 'Percent of Early Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device - CEP Mitral Valve', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}], 'classes': [{'title': 'Thromboembolism', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Valve Thrombosis', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'All Bleeding Events', 'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000'}]}]}, {'title': 'Major bleeding', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000'}]}]}, {'title': 'Endocarditis', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Hemolysis', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Structural Valve Deterioration', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Non-Structural Valve Dysfunction', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Reoperation', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Explant', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Events occurring within 30 days of procedure', 'description': 'Total number of early adverse events, in each category, occurring within 30 days of procedure divided by the number of enrolled subjects times 100.', 'unitOfMeasure': 'percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.'}, {'type': 'SECONDARY', 'title': "Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time", 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device - CEP Mitral Valve', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '63.1', 'spread': '20.7', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '75.4', 'spread': '17.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months post-implant', 'description': 'The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale ranges from a minimum of 0 and a maximum of 100. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.'}, {'type': 'SECONDARY', 'title': 'Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device - CEP Mitral Valve', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}], 'classes': [{'title': 'Thromboembolism', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}]}]}, {'title': 'Valve Thrombosis', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}]}]}, {'title': 'All Bleeding Events', 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000'}]}]}, {'title': 'Major bleeding', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}]}]}, {'title': 'Endocarditis', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'Hemolysis', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Structural Valve Deterioration', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Non-Structural Valve Dysfunction', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Reoperation', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}]}]}, {'title': 'Explant', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Events occurring ≥ 31 days and up through 8 years post-implant', 'description': "A linearized rate percentage is calculated by the following equation: \\[(Total number of late adverse events in each category/total number of late patient years) x 100\\]. Late adverse events are events that occur ≥ 31 days post-implant through each subject's last follow-up visit or contact. Late patient years are calculated by totaling the amount of time the valve is implanted in the patient while participating in the trial and the count begins at ≥ 31 days post-implant through all subject's last follow-up visit or contact.", 'unitOfMeasure': 'Linearized rate percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve.'}, {'type': 'SECONDARY', 'title': "Subject's Average Mean Gradient Measurement", 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device - CEP Mitral Valve', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.03', 'spread': '5.42', 'groupId': 'OG000'}]}]}, {'title': '8 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.70', 'spread': '2.85', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 years post-implant', 'description': 'Mean gradient is the average flow of blood through the mitral valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.'}, {'type': 'SECONDARY', 'title': "Subject's Average Peak Gradient Measurement", 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device - CEP Mitral Valve', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.56', 'spread': '9.63', 'groupId': 'OG000'}]}]}, {'title': '8 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.57', 'spread': '6.62', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 years post-implant', 'description': 'Peak gradient is the maximum value measured of flow of blood through the mitral valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher valve is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.'}, {'type': 'SECONDARY', 'title': "Subject's Average Effective Orifice Area (EOA) Measurement", 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device - CEP Mitral Valve', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.39', 'spread': '0.93', 'groupId': 'OG000'}]}]}, {'title': '8 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.90', 'spread': '0.67', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 years post-implant', 'description': 'Effective orifice area represents the cross-sectional area of the blood flow downstream of the mitral valve. Effective orifice area is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size and type of valve.', 'unitOfMeasure': 'cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.'}, {'type': 'SECONDARY', 'title': "Subject's Average Effective Orifice Area Index (EOAI) Measurement", 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device - CEP Mitral Valve', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.73', 'spread': '0.48', 'groupId': 'OG000'}]}]}, {'title': '8 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.03', 'spread': '0.38', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 years post-implant', 'description': "Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the mitral valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient and the size and type of valve.", 'unitOfMeasure': 'cm^2/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.'}, {'type': 'SECONDARY', 'title': "Subject's Average Cardiac Output Measurement", 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device - CEP Mitral Valve', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.70', 'spread': '1.67', 'groupId': 'OG000'}]}]}, {'title': '8 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.02', 'spread': '1.52', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 years post-implant', 'description': 'Cardiac output is the amount of blood the heart pumps through the circulatory system in a minute. Cardiac output is evaluated by echocardiography over time. Normal cardiac output in healthy volunteers over 60 years of age was reported between 3.1 and 6.4 liters per minute. In general, a higher value is considered better, and a lower value is considered worse.', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.'}, {'type': 'SECONDARY', 'title': "Subject's Average Cardiac Index Measurement", 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device - CEP Mitral Valve', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.50', 'spread': '0.86', 'groupId': 'OG000'}]}]}, {'title': '8 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.32', 'spread': '0.91', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 years post-implant', 'description': "Cardiac index (CI) evaluated by echocardiography. Cardiac index is an assessment of the cardiac output value based on the patient's size. To obtain the cardiac index, divide the cardiac output by the person's body surface area (BSA). Cardiac Index is a useful marker of how well the heart is functioning as a pump by directly correlating the volume of blood pumped by the heart with an individual's body surface area. Normal cardiac output index in healthy volunteers over 60 years of age was reported between 1.1 and 3.2 L/min/m\\^2. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient.", 'unitOfMeasure': 'L/min/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.'}, {'type': 'SECONDARY', 'title': "Subject's Average Left Ventricular Mass Regression", 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device - CEP Mitral Valve', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '213.21', 'spread': '90.50', 'groupId': 'OG000'}]}]}, {'title': '8 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '163.71', 'spread': '54.50', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 years post-implant', 'description': 'Patients can experience an enlargement of the left ventricle (chamber) of their heart because it works harder with a defective heart valve. Left ventricular mass regression evaluates if the patient experiences a decrease in the size of the left ventricle (chamber) after the repair or replacement of their heart valve.', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.'}, {'type': 'SECONDARY', 'title': "Subject's Average Red Blood Cell Count", 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Device - CEP Mitral Valve - 25mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG001', 'title': 'Device - CEP Mitral Valve - 27mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG002', 'title': 'Device - CEP Mitral Valve - 29mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG003', 'title': 'Device - CEP Mitral Valve - 31mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG004', 'title': 'Device - CEP Mitral Valve - 33mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}], 'classes': [{'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '4.3', 'spread': '0.6', 'groupId': 'OG003'}, {'value': '4.6', 'spread': '0.5', 'groupId': 'OG004'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '4.2', 'spread': '0.6', 'groupId': 'OG003'}, {'value': '4.6', 'spread': '0.4', 'groupId': 'OG004'}]}]}, {'title': '2 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '4.3', 'spread': '0.6', 'groupId': 'OG003'}, {'value': '4.6', 'spread': '0.3', 'groupId': 'OG004'}]}]}, {'title': '3 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '4.3', 'spread': '0.7', 'groupId': 'OG003'}, {'value': '4.6', 'spread': '0.3', 'groupId': 'OG004'}]}]}, {'title': '4 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '4.4', 'spread': '0.6', 'groupId': 'OG003'}, {'value': '4.6', 'spread': '0.3', 'groupId': 'OG004'}]}]}, {'title': '5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '4.2', 'spread': '0.8', 'groupId': 'OG003'}, {'value': '4.5', 'spread': '0.4', 'groupId': 'OG004'}]}]}, {'title': '6 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '4.3', 'spread': '0.8', 'groupId': 'OG003'}, {'value': '4.6', 'spread': '0.4', 'groupId': 'OG004'}]}]}, {'title': '7 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '4.1', 'spread': '0.8', 'groupId': 'OG003'}, {'value': '4.6', 'spread': '0.3', 'groupId': 'OG004'}]}]}, {'title': '8 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '4.1', 'spread': '1.0', 'groupId': 'OG003'}, {'value': '4.4', 'spread': '0.4', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits', 'description': "The red blood cell (RBC) count is a test that measures the number of oxygen-carrying blood cells in your blood. The red blood cell count normal range for women is 4.2 to 5.4 10\\^6 cells/microliters and for men is 4.7 to 6.1 10\\^6 cells/microliters. A high red blood cell count may indicate that you have a condition that's preventing you from getting enough oxygen. A low RBC may be caused by an infection, or a medical condition related to anemia. In general, results either lower or higher than the normal range may indicate something is wrong.", 'unitOfMeasure': '10^6 cells/uL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.'}, {'type': 'SECONDARY', 'title': "Subject's Average White Blood Cell Count", 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Device - CEP Mitral Valve - 25mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG001', 'title': 'Device - CEP Mitral Valve - 27mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG002', 'title': 'Device - CEP Mitral Valve - 29mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG003', 'title': 'Device - CEP Mitral Valve - 31mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG004', 'title': 'Device - CEP Mitral Valve - 33mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}], 'classes': [{'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.9', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '7.2', 'spread': '2.1', 'groupId': 'OG002'}, {'value': '7.1', 'spread': '2.2', 'groupId': 'OG003'}, {'value': '6.7', 'spread': '1.2', 'groupId': 'OG004'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7.1', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '7.1', 'spread': '1.8', 'groupId': 'OG002'}, {'value': '7.5', 'spread': '2.0', 'groupId': 'OG003'}, {'value': '7.2', 'spread': '1.3', 'groupId': 'OG004'}]}]}, {'title': '2 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.9', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '7.2', 'spread': '2.0', 'groupId': 'OG002'}, {'value': '6.5', 'spread': '1.8', 'groupId': 'OG003'}, {'value': '5.8', 'spread': '1.2', 'groupId': 'OG004'}]}]}, {'title': '3 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.5', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '7.0', 'spread': '2.2', 'groupId': 'OG002'}, {'value': '7.1', 'spread': '2.2', 'groupId': 'OG003'}, {'value': '6.1', 'spread': '1.3', 'groupId': 'OG004'}]}]}, {'title': '4 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.9', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '7.6', 'spread': '2.6', 'groupId': 'OG002'}, {'value': '6.5', 'spread': '1.6', 'groupId': 'OG003'}, {'value': '6.0', 'spread': '1.3', 'groupId': 'OG004'}]}]}, {'title': '5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.2', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '7.3', 'spread': '2.2', 'groupId': 'OG002'}, {'value': '6.8', 'spread': '1.7', 'groupId': 'OG003'}, {'value': '6.9', 'spread': '3.8', 'groupId': 'OG004'}]}]}, {'title': '6 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.4', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '6.9', 'spread': '2.1', 'groupId': 'OG002'}, {'value': '7.4', 'spread': '1.8', 'groupId': 'OG003'}, {'value': '5.9', 'spread': '1.0', 'groupId': 'OG004'}]}]}, {'title': '7 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.8', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '7.0', 'spread': '2.2', 'groupId': 'OG002'}, {'value': '6.7', 'spread': '2.1', 'groupId': 'OG003'}, {'value': '6.1', 'spread': '1.7', 'groupId': 'OG004'}]}]}, {'title': '8 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.0', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '7.9', 'spread': '2.1', 'groupId': 'OG002'}, {'value': '5.8', 'spread': '1.5', 'groupId': 'OG003'}, {'value': '6.6', 'spread': '1.1', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits', 'description': 'Laboratory analysis of White Blood Cell (WBC) count on blood drawn from subject; WBC fight infection. The normal reference range for WBC count is 4.5 to 10.0 10\\^3 cells/microliters. In general, results either lower or higher than the normal range can indicate something is wrong.', 'unitOfMeasure': '10^3 cells/uL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.'}, {'type': 'SECONDARY', 'title': "Subject's Average Hemoglobin Count", 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Device - CEP Mitral Valve - 25mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG001', 'title': 'Device - CEP Mitral Valve - 27mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG002', 'title': 'Device - CEP Mitral Valve - 29mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG003', 'title': 'Device - CEP Mitral Valve - 31mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG004', 'title': 'Device - CEP Mitral Valve - 33mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}], 'classes': [{'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12.4', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '12.5', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '12.8', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '12.8', 'spread': '1.6', 'groupId': 'OG003'}, {'value': '13.7', 'spread': '2.2', 'groupId': 'OG004'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12.9', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '12.8', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '13.3', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '12.9', 'spread': '1.7', 'groupId': 'OG003'}, {'value': '13.9', 'spread': '1.4', 'groupId': 'OG004'}]}]}, {'title': '2 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12.5', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '13.2', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '13.3', 'spread': '1.7', 'groupId': 'OG002'}, {'value': '13.2', 'spread': '1.9', 'groupId': 'OG003'}, {'value': '14.0', 'spread': '1.1', 'groupId': 'OG004'}]}]}, {'title': '3 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12.9', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '13.0', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '13.1', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '13.1', 'spread': '2.0', 'groupId': 'OG003'}, {'value': '14.0', 'spread': '1.8', 'groupId': 'OG004'}]}]}, {'title': '4 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12.6', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '13.0', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '12.9', 'spread': '1.6', 'groupId': 'OG002'}, {'value': '13.6', 'spread': '1.7', 'groupId': 'OG003'}, {'value': '14.2', 'spread': '0.7', 'groupId': 'OG004'}]}]}, {'title': '5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13.1', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '13.0', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '13.0', 'spread': '1.6', 'groupId': 'OG002'}, {'value': '13.0', 'spread': '2.3', 'groupId': 'OG003'}, {'value': '13.8', 'spread': '1.4', 'groupId': 'OG004'}]}]}, {'title': '6 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12.5', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '12.7', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '12.7', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '13.4', 'spread': '2.0', 'groupId': 'OG003'}, {'value': '14.4', 'spread': '1.1', 'groupId': 'OG004'}]}]}, {'title': '7 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12.8', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '12.7', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '12.3', 'spread': '1.8', 'groupId': 'OG002'}, {'value': '12.7', 'spread': '2.3', 'groupId': 'OG003'}, {'value': '14.0', 'spread': '1.5', 'groupId': 'OG004'}]}]}, {'title': '8 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12.5', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '12.8', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '13.1', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '12.8', 'spread': '2.7', 'groupId': 'OG003'}, {'value': '13.6', 'spread': '1.8', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits', 'description': 'This is the laboratory analysis of Hemoglobin count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells. In males, a healthy hemoglobin level is between 13.2 and 16.6 g/dL. In females, a hemoglobin count of between 11.6 and 15 g/dL is considered normal and healthy. In general, results either lower or higher than the normal range can indicate something is wrong.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.'}, {'type': 'SECONDARY', 'title': "Subject's Average Hematocrit Count", 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Device - CEP Mitral Valve - 25mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG001', 'title': 'Device - CEP Mitral Valve - 27mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG002', 'title': 'Device - CEP Mitral Valve - 29mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG003', 'title': 'Device - CEP Mitral Valve - 31mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG004', 'title': 'Device - CEP Mitral Valve - 33mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}], 'classes': [{'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '38.0', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '37.9', 'spread': '4.3', 'groupId': 'OG001'}, {'value': '38.7', 'spread': '3.8', 'groupId': 'OG002'}, {'value': '38.6', 'spread': '4.8', 'groupId': 'OG003'}, {'value': '40.7', 'spread': '5.9', 'groupId': 'OG004'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '39.4', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '38.6', 'spread': '4.3', 'groupId': 'OG001'}, {'value': '39.7', 'spread': '4.1', 'groupId': 'OG002'}, {'value': '38.6', 'spread': '4.8', 'groupId': 'OG003'}, {'value': '41.6', 'spread': '3.6', 'groupId': 'OG004'}]}]}, {'title': '2 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '39.0', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '39.6', 'spread': '3.7', 'groupId': 'OG001'}, {'value': '40.0', 'spread': '4.7', 'groupId': 'OG002'}, {'value': '39.9', 'spread': '5.1', 'groupId': 'OG003'}, {'value': '41.6', 'spread': '3.1', 'groupId': 'OG004'}]}]}, {'title': '3 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '39.4', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '39.1', 'spread': '4.3', 'groupId': 'OG001'}, {'value': '39.5', 'spread': '3.8', 'groupId': 'OG002'}, {'value': '39.4', 'spread': '5.2', 'groupId': 'OG003'}, {'value': '41.7', 'spread': '5.0', 'groupId': 'OG004'}]}]}, {'title': '4 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '39.0', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '39.4', 'spread': '3.9', 'groupId': 'OG001'}, {'value': '39.2', 'spread': '4.3', 'groupId': 'OG002'}, {'value': '40.9', 'spread': '4.3', 'groupId': 'OG003'}, {'value': '42.4', 'spread': '1.2', 'groupId': 'OG004'}]}]}, {'title': '5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '40.0', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '39.7', 'spread': '4.6', 'groupId': 'OG001'}, {'value': '39.8', 'spread': '4.7', 'groupId': 'OG002'}, {'value': '39.4', 'spread': '6.5', 'groupId': 'OG003'}, {'value': '41.0', 'spread': '3.7', 'groupId': 'OG004'}]}]}, {'title': '6 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '38.7', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '39.3', 'spread': '4.6', 'groupId': 'OG001'}, {'value': '38.8', 'spread': '4.0', 'groupId': 'OG002'}, {'value': '40.3', 'spread': '5.9', 'groupId': 'OG003'}, {'value': '42.3', 'spread': '3.1', 'groupId': 'OG004'}]}]}, {'title': '7 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '39.8', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '37.3', 'spread': '8.2', 'groupId': 'OG001'}, {'value': '38.1', 'spread': '5.1', 'groupId': 'OG002'}, {'value': '38.1', 'spread': '6.1', 'groupId': 'OG003'}, {'value': '42.4', 'spread': '4.4', 'groupId': 'OG004'}]}]}, {'title': '8 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '38.6', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '39.6', 'spread': '5.1', 'groupId': 'OG001'}, {'value': '39.8', 'spread': '4.2', 'groupId': 'OG002'}, {'value': '38.5', 'spread': '7.4', 'groupId': 'OG003'}, {'value': '40.9', 'spread': '5.3', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits', 'description': 'This is laboratory analysis of Hematocrit percentage on blood drawn from subjects. A hematocrit test measures the proportion of red blood cells in your blood. Red blood cells carry oxygen throughout your body. Having too few or too many red blood cells can be a sign of certain diseases. Normal hematocrit ranges for adult females are 36% to 44% and for adult males are 41% to 50%. In general, results either lower or higher than the normal range can indicate something is wrong.', 'unitOfMeasure': 'Percentage of red blood cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.'}, {'type': 'SECONDARY', 'title': "Subject's Average Reticulocytes Percentage Over Time", 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Device - CEP Mitral Valve - 25mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG001', 'title': 'Device - CEP Mitral Valve - 27mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG002', 'title': 'Device - CEP Mitral Valve - 29mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG003', 'title': 'Device - CEP Mitral Valve - 31mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG004', 'title': 'Device - CEP Mitral Valve - 33mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}], 'classes': [{'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '1.2', 'spread': '0.6', 'groupId': 'OG003'}, {'value': '1.1', 'spread': '0.4', 'groupId': 'OG004'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '1.3', 'spread': '0.5', 'groupId': 'OG003'}, {'value': '1.2', 'spread': '0.6', 'groupId': 'OG004'}]}]}, {'title': '2 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '1.2', 'spread': '0.4', 'groupId': 'OG003'}, {'value': '2.9', 'spread': '4.9', 'groupId': 'OG004'}]}]}, {'title': '3 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '1.3', 'spread': '0.5', 'groupId': 'OG003'}, {'value': '1.2', 'spread': '0.6', 'groupId': 'OG004'}]}]}, {'title': '4 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '10.3', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '0.5', 'groupId': 'OG002'}, {'value': '1.2', 'spread': '0.4', 'groupId': 'OG003'}, {'value': '1.1', 'spread': '0.4', 'groupId': 'OG004'}]}]}, {'title': '5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '6.6', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '1.4', 'spread': '0.4', 'groupId': 'OG003'}, {'value': '1.3', 'spread': '0.5', 'groupId': 'OG004'}]}]}, {'title': '6 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '1.4', 'spread': '0.4', 'groupId': 'OG003'}, {'value': '1.1', 'spread': '0.3', 'groupId': 'OG004'}]}]}, {'title': '7 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '2.8', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '1.3', 'spread': '0.5', 'groupId': 'OG003'}, {'value': '1.2', 'spread': '0.2', 'groupId': 'OG004'}]}]}, {'title': '8 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '2.8', 'groupId': 'OG002'}, {'value': '1.6', 'spread': '0.8', 'groupId': 'OG003'}, {'value': '1.5', 'spread': '0.3', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits', 'description': 'Laboratory Analysis of reticulocytes on blood drawn from subjects. Reticulocytes are newly produced immature red blood cells; a reticulocyte blood test measures the amount of these cells in the blood. The reference range for reticulocytes is 0.5 - 2.6 % of red blood cells. In general, results either lower or higher than the normal range can indicate something is wrong.', 'unitOfMeasure': 'Percentage of reticulocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.'}, {'type': 'SECONDARY', 'title': "Subject's Average Platelet Count Over Time", 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Device - CEP Mitral Valve - 25mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG001', 'title': 'Device - CEP Mitral Valve - 27mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG002', 'title': 'Device - CEP Mitral Valve - 29mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG003', 'title': 'Device - CEP Mitral Valve - 31mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG004', 'title': 'Device - CEP Mitral Valve - 33mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}], 'classes': [{'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '242.2', 'spread': '85.7', 'groupId': 'OG000'}, {'value': '218.5', 'spread': '83.7', 'groupId': 'OG001'}, {'value': '211.6', 'spread': '68.9', 'groupId': 'OG002'}, {'value': '202.0', 'spread': '49.2', 'groupId': 'OG003'}, {'value': '202.0', 'spread': '58.4', 'groupId': 'OG004'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '224.3', 'spread': '64.9', 'groupId': 'OG000'}, {'value': '214.7', 'spread': '76.9', 'groupId': 'OG001'}, {'value': '201.6', 'spread': '69.1', 'groupId': 'OG002'}, {'value': '196.0', 'spread': '42.1', 'groupId': 'OG003'}, {'value': '201.5', 'spread': '54.2', 'groupId': 'OG004'}]}]}, {'title': '2 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '217.1', 'spread': '66.8', 'groupId': 'OG000'}, {'value': '208.9', 'spread': '70.2', 'groupId': 'OG001'}, {'value': '208.4', 'spread': '80.5', 'groupId': 'OG002'}, {'value': '190.6', 'spread': '35.9', 'groupId': 'OG003'}, {'value': '175.9', 'spread': '31.0', 'groupId': 'OG004'}]}]}, {'title': '3 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '208.0', 'spread': '87.2', 'groupId': 'OG000'}, {'value': '210.8', 'spread': '80.2', 'groupId': 'OG001'}, {'value': '200.3', 'spread': '86.6', 'groupId': 'OG002'}, {'value': '197.4', 'spread': '45.8', 'groupId': 'OG003'}, {'value': '191.0', 'spread': '48.9', 'groupId': 'OG004'}]}]}, {'title': '4 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '207.2', 'spread': '79.7', 'groupId': 'OG000'}, {'value': '212.0', 'spread': '78.6', 'groupId': 'OG001'}, {'value': '213.8', 'spread': '108.2', 'groupId': 'OG002'}, {'value': '188.1', 'spread': '45.6', 'groupId': 'OG003'}, {'value': '190.9', 'spread': '40.3', 'groupId': 'OG004'}]}]}, {'title': '5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '203.5', 'spread': '64.5', 'groupId': 'OG000'}, {'value': '208.1', 'spread': '74.6', 'groupId': 'OG001'}, {'value': '207.4', 'spread': '123.8', 'groupId': 'OG002'}, {'value': '177.7', 'spread': '37.6', 'groupId': 'OG003'}, {'value': '212.2', 'spread': '65.7', 'groupId': 'OG004'}]}]}, {'title': '6 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '197.0', 'spread': '61.3', 'groupId': 'OG000'}, {'value': '214.3', 'spread': '90.9', 'groupId': 'OG001'}, {'value': '224.0', 'spread': '197.2', 'groupId': 'OG002'}, {'value': '190.4', 'spread': '35.0', 'groupId': 'OG003'}, {'value': '185.3', 'spread': '27.3', 'groupId': 'OG004'}]}]}, {'title': '7 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '203.4', 'spread': '60.2', 'groupId': 'OG000'}, {'value': '219.6', 'spread': '77.3', 'groupId': 'OG001'}, {'value': '237.2', 'spread': '197.9', 'groupId': 'OG002'}, {'value': '202.4', 'spread': '46.7', 'groupId': 'OG003'}, {'value': '181.5', 'spread': '37.1', 'groupId': 'OG004'}]}]}, {'title': '8 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '175.1', 'spread': '48.4', 'groupId': 'OG000'}, {'value': '225.1', 'spread': '92.3', 'groupId': 'OG001'}, {'value': '198.8', 'spread': '53.6', 'groupId': 'OG002'}, {'value': '189.3', 'spread': '40.5', 'groupId': 'OG003'}, {'value': '177.8', 'spread': '27.9', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits', 'description': 'This is laboratory analysis of Platelet count on blood drawn from subjects. The purpose of platelets is to create hemostasis, which is the prevention of hemorrhaging (bleeding) and the process of keeping blood inside the vessel walls. A normal platelet range is 150 to 450 10\\^3 cells/microliter. In general, results either lower or higher than the normal range can indicate something is wrong.', 'unitOfMeasure': '10^3 cells/microliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.'}, {'type': 'SECONDARY', 'title': "Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time", 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Device - CEP Mitral Valve - 25mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG001', 'title': 'Device - CEP Mitral Valve - 27mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG002', 'title': 'Device - CEP Mitral Valve - 29mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG003', 'title': 'Device - CEP Mitral Valve - 31mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG004', 'title': 'Device - CEP Mitral Valve - 33mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}], 'classes': [{'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '241.4', 'spread': '48.4', 'groupId': 'OG000'}, {'value': '247.3', 'spread': '100.1', 'groupId': 'OG001'}, {'value': '322.5', 'spread': '189.8', 'groupId': 'OG002'}, {'value': '274.2', 'spread': '141.0', 'groupId': 'OG003'}, {'value': '300.5', 'spread': '182.0', 'groupId': 'OG004'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '232.7', 'spread': '44.0', 'groupId': 'OG000'}, {'value': '250.2', 'spread': '100.4', 'groupId': 'OG001'}, {'value': '294.5', 'spread': '145.0', 'groupId': 'OG002'}, {'value': '229.5', 'spread': '103.1', 'groupId': 'OG003'}, {'value': '472.3', 'spread': '223.8', 'groupId': 'OG004'}]}]}, {'title': '2 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '228.7', 'spread': '54.0', 'groupId': 'OG000'}, {'value': '231.9', 'spread': '82.0', 'groupId': 'OG001'}, {'value': '263.8', 'spread': '103.1', 'groupId': 'OG002'}, {'value': '209.1', 'spread': '51.6', 'groupId': 'OG003'}, {'value': '405.3', 'spread': '219.8', 'groupId': 'OG004'}]}]}, {'title': '3 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '243.1', 'spread': '41.4', 'groupId': 'OG000'}, {'value': '227.0', 'spread': '66.0', 'groupId': 'OG001'}, {'value': '274.7', 'spread': '102.0', 'groupId': 'OG002'}, {'value': '240.2', 'spread': '56.4', 'groupId': 'OG003'}, {'value': '332.5', 'spread': '149.2', 'groupId': 'OG004'}]}]}, {'title': '4 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '243.0', 'spread': '53.1', 'groupId': 'OG000'}, {'value': '220.1', 'spread': '45.0', 'groupId': 'OG001'}, {'value': '247.8', 'spread': '33.7', 'groupId': 'OG002'}, {'value': '251.0', 'spread': '43.7', 'groupId': 'OG003'}, {'value': '286.0', 'spread': '127.3', 'groupId': 'OG004'}]}]}, {'title': '5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '227.3', 'spread': '23.7', 'groupId': 'OG000'}, {'value': '227.3', 'spread': '42.5', 'groupId': 'OG001'}, {'value': '221.4', 'spread': '31.3', 'groupId': 'OG002'}, {'value': '238.5', 'spread': '19.1', 'groupId': 'OG003'}, {'value': '287.0', 'spread': '118.8', 'groupId': 'OG004'}]}]}, {'title': '6 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '256.7', 'spread': '71.3', 'groupId': 'OG000'}, {'value': '248.5', 'spread': '94.4', 'groupId': 'OG001'}, {'value': '245.3', 'spread': '33.8', 'groupId': 'OG002'}, {'value': '269.3', 'spread': '43.0', 'groupId': 'OG003'}, {'value': '393', 'groupId': 'OG004'}]}]}, {'title': '7 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '202.5', 'spread': '109.7', 'groupId': 'OG001'}, {'value': '255.8', 'spread': '24.2', 'groupId': 'OG002'}, {'value': '254.0', 'spread': '22.0', 'groupId': 'OG003'}, {'value': '200.0', 'groupId': 'OG004'}]}]}, {'title': '8 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '253.0', 'groupId': 'OG000'}, {'value': '254.5', 'spread': '56.1', 'groupId': 'OG001'}, {'value': '257.4', 'spread': '28.4', 'groupId': 'OG002'}, {'value': '369.7', 'spread': '189.7', 'groupId': 'OG003'}, {'value': '423.0', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits', 'description': "The serum lactate dehydrogenase (LDH) test looks for signs of damage to the body's tissues. Normal levels of LDH in the blood can vary depending on the lab but usually range between 140 units per liter (U/L) to 280 U/L for adults and tend to be higher for children and teens. In general, results either lower or higher than the normal range can indicate something is wrong.", 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. The protocol allowed subjects to have the option of having (haptoglobin and SLDH tests) or alternatively a plasma free hemoglobin test at each timeframe. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.'}, {'type': 'SECONDARY', 'title': "Subject's Average Plasma Free Hemoglobin Over Time", 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Device - CEP Mitral Valve - 25mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG001', 'title': 'Device - CEP Mitral Valve - 27mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG002', 'title': 'Device - CEP Mitral Valve - 29mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG003', 'title': 'Device - CEP Mitral Valve - 31mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG004', 'title': 'Device - CEP Mitral Valve - 33mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}], 'classes': [{'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10.7', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '8.3', 'spread': '7.2', 'groupId': 'OG001'}, {'value': '14.4', 'spread': '23.4', 'groupId': 'OG002'}, {'value': '17.8', 'spread': '35.3', 'groupId': 'OG003'}, {'value': '20.1', 'spread': '19.0', 'groupId': 'OG004'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '16.3', 'spread': '17.5', 'groupId': 'OG000'}, {'value': '11.7', 'spread': '11.6', 'groupId': 'OG001'}, {'value': '11.5', 'spread': '13.5', 'groupId': 'OG002'}, {'value': '18.3', 'spread': '25.7', 'groupId': 'OG003'}, {'value': '12.6', 'spread': '8.0', 'groupId': 'OG004'}]}]}, {'title': '2 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '15.2', 'spread': '19.3', 'groupId': 'OG000'}, {'value': '14.0', 'spread': '18.4', 'groupId': 'OG001'}, {'value': '7.9', 'spread': '6.5', 'groupId': 'OG002'}, {'value': '17.0', 'spread': '14.0', 'groupId': 'OG003'}, {'value': '12.3', 'spread': '7.6', 'groupId': 'OG004'}]}]}, {'title': '3 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '15.8', 'spread': '20.1', 'groupId': 'OG000'}, {'value': '11.6', 'spread': '14.2', 'groupId': 'OG001'}, {'value': '9.0', 'spread': '8.7', 'groupId': 'OG002'}, {'value': '7.4', 'spread': '5.3', 'groupId': 'OG003'}, {'value': '15.4', 'spread': '8.9', 'groupId': 'OG004'}]}]}, {'title': '4 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '26.3', 'spread': '35.2', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '7.5', 'groupId': 'OG001'}, {'value': '13.6', 'spread': '29.9', 'groupId': 'OG002'}, {'value': '16.2', 'spread': '21.8', 'groupId': 'OG003'}, {'value': '10.0', 'spread': '3.2', 'groupId': 'OG004'}]}]}, {'title': '5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13.8', 'spread': '17.6', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '5.8', 'groupId': 'OG001'}, {'value': '9.7', 'spread': '9.5', 'groupId': 'OG002'}, {'value': '9.6', 'spread': '10.9', 'groupId': 'OG003'}, {'value': '17.0', 'spread': '7.8', 'groupId': 'OG004'}]}]}, {'title': '6 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '14.0', 'spread': '15.0', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '4.1', 'groupId': 'OG001'}, {'value': '12.2', 'spread': '13.7', 'groupId': 'OG002'}, {'value': '12.1', 'spread': '11.9', 'groupId': 'OG003'}, {'value': '29.8', 'spread': '40.2', 'groupId': 'OG004'}]}]}, {'title': '7 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '20.6', 'spread': '32.1', 'groupId': 'OG000'}, {'value': '12.3', 'spread': '24.5', 'groupId': 'OG001'}, {'value': '20.7', 'spread': '31.5', 'groupId': 'OG002'}, {'value': '8.5', 'spread': '5.6', 'groupId': 'OG003'}, {'value': '9.0', 'spread': '4.8', 'groupId': 'OG004'}]}]}, {'title': '8 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '14.2', 'spread': '12.2', 'groupId': 'OG000'}, {'value': '11.5', 'spread': '9.7', 'groupId': 'OG001'}, {'value': '12.5', 'spread': '11.2', 'groupId': 'OG002'}, {'value': '13.7', 'spread': '11.8', 'groupId': 'OG003'}, {'value': '8.0', 'spread': '2.9', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits', 'description': 'Laboratory analysis of Plasma Free Hemoglobin (Pf Hgb) of blood drawn from subject. This blood test measures the level of free hemoglobin in the plasma (liquid portion of the blood). The reference range for plasma free hemoglobin is 0.0 to 15.2 mg/dL. In general, values higher than this can indicate something is wrong.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. The protocol allowed subjects to have the option of having a plasma free hemoglobin test or alternatively a (haptoglobin and SLDH tests) at each timeframe. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.'}, {'type': 'SECONDARY', 'title': "Subject's Average Haptoglobin Over Time", 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Device - CEP Mitral Valve - 25mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG001', 'title': 'Device - CEP Mitral Valve - 27mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG002', 'title': 'Device - CEP Mitral Valve - 29mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG003', 'title': 'Device - CEP Mitral Valve - 31mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}, {'id': 'OG004', 'title': 'Device - CEP Mitral Valve - 33mm', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}], 'classes': [{'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '118.7', 'spread': '59.0', 'groupId': 'OG000'}, {'value': '143.9', 'spread': '90.8', 'groupId': 'OG001'}, {'value': '118.0', 'spread': '63.6', 'groupId': 'OG002'}, {'value': '119.2', 'spread': '65.5', 'groupId': 'OG003'}, {'value': '70.9', 'spread': '68.4', 'groupId': 'OG004'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '110.0', 'spread': '52.0', 'groupId': 'OG000'}, {'value': '120.8', 'spread': '68.9', 'groupId': 'OG001'}, {'value': '107.9', 'spread': '67.0', 'groupId': 'OG002'}, {'value': '128.3', 'spread': '60.5', 'groupId': 'OG003'}, {'value': '123.7', 'spread': '62.1', 'groupId': 'OG004'}]}]}, {'title': '2 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '110.1', 'spread': '38.9', 'groupId': 'OG000'}, {'value': '127.1', 'spread': '76.2', 'groupId': 'OG001'}, {'value': '124.2', 'spread': '57.6', 'groupId': 'OG002'}, {'value': '101.8', 'spread': '48.3', 'groupId': 'OG003'}, {'value': '109.8', 'spread': '89.4', 'groupId': 'OG004'}]}]}, {'title': '3 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '103.6', 'spread': '46.6', 'groupId': 'OG000'}, {'value': '139.2', 'spread': '80.3', 'groupId': 'OG001'}, {'value': '96.2', 'spread': '52.5', 'groupId': 'OG002'}, {'value': '117.0', 'spread': '36.1', 'groupId': 'OG003'}, {'value': '109.0', 'spread': '19.8', 'groupId': 'OG004'}]}]}, {'title': '4 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '111.4', 'spread': '54.9', 'groupId': 'OG000'}, {'value': '139.9', 'spread': '77.9', 'groupId': 'OG001'}, {'value': '97.6', 'spread': '49.6', 'groupId': 'OG002'}, {'value': '96.9', 'spread': '53.5', 'groupId': 'OG003'}, {'value': '81.1', 'spread': '113.0', 'groupId': 'OG004'}]}]}, {'title': '5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '79.0', 'spread': '49.1', 'groupId': 'OG000'}, {'value': '152.4', 'spread': '81.5', 'groupId': 'OG001'}, {'value': '111.6', 'spread': '56.3', 'groupId': 'OG002'}, {'value': '80.2', 'spread': '91.6', 'groupId': 'OG003'}, {'value': '120.1', 'spread': '168.1', 'groupId': 'OG004'}]}]}, {'title': '6 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '118.7', 'spread': '95.5', 'groupId': 'OG000'}, {'value': '109.8', 'spread': '71.4', 'groupId': 'OG001'}, {'value': '103.6', 'spread': '58.6', 'groupId': 'OG002'}, {'value': '126.8', 'spread': '37.9', 'groupId': 'OG003'}, {'value': '151.0', 'spread': '70.7', 'groupId': 'OG004'}]}]}, {'title': '7 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '85.2', 'spread': '78.0', 'groupId': 'OG001'}, {'value': '107.2', 'spread': '72.6', 'groupId': 'OG002'}, {'value': '51.7', 'spread': '40.2', 'groupId': 'OG003'}, {'value': '239.0', 'groupId': 'OG004'}]}]}, {'title': '8 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '115.0', 'groupId': 'OG000'}, {'value': '129.0', 'spread': '23.3', 'groupId': 'OG001'}, {'value': '106.4', 'spread': '40.0', 'groupId': 'OG002'}, {'value': '96.0', 'spread': '22.6', 'groupId': 'OG003'}, {'value': '117.0', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits', 'description': 'Haptoglobin is a protein produced by your liver. It binds with hemoglobin, which is a protein found in red blood cells. When red blood cells are destroyed, they release hemoglobin. The released hemoglobin is called "free hemoglobin." Haptoglobin attaches to the free hemoglobin to create a haptoglobin-hemoglobin complex. This complex travels to the liver, where it\'s removed from the body. A normal haptoglobin level falls between 45 and 200 milligrams of haptoglobin per deciliter of blood. In general, results either lower or higher than the normal range can indicate something is wrong.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is reported for subjects who received an Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve. The protocol allowed subjects to have the option of having (haptoglobin and SLDH tests) or alternatively a plasma free hemoglobin test at each timeframe. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Device - CEP Mitral Valve', 'description': 'Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '329'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '127'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '202'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '88'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '45'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'Reoperation/Explant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'Exit with other reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Device - CEP Mitral Valve', 'description': 'Subjects who received a Carpentier-Edwards PERIMOUNT Magna Mitral surgical heart valve'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '69.7', 'spread': '10.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '201', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '128', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}]}]}, {'title': 'Europe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '105', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '169', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Subjects implanted with a Carpentier-Edwards PERIMOUNT Magna Mitral heart valve.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-11-18', 'size': 8042840, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2025-01-23T13:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 329}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2009-02-26', 'resultsFirstSubmitDate': '2025-03-07', 'studyFirstSubmitQcDate': '2009-02-27', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-12', 'studyFirstPostDateStruct': {'date': '2009-03-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Subject's Rate of Objective Performance Criteria Per ISO 5840-2005 - Total Number of Late Adverse Events (by Category) Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort", 'timeFrame': 'Events occurring ≥ 31 days and up through 8 years post-implant', 'description': "A linearized rate percentage is calculated by the following equation: \\[(Total number of late adverse events in each category/total number of late patient years) x 100\\]. Late adverse events are events that occur ≥ 31 days post-implant through each subject's last follow-up visit or contact. Late patient years are calculated by totaling the amount of time the valve is implanted in the patient while participating in the trial and the count begins at ≥ 31 days post-implant through all subject's last follow-up visit or contact."}, {'measure': 'Primary Effectiveness Endpoints', 'timeFrame': '8 years post-implant', 'description': 'The primary effectiveness endpoint will be the percentage of subjects in NYHA functional classification I or II at 8 years post-implant.'}], 'secondaryOutcomes': [{'measure': 'Percent of Early Adverse Events', 'timeFrame': 'Events occurring within 30 days of procedure', 'description': 'Total number of early adverse events, in each category, occurring within 30 days of procedure divided by the number of enrolled subjects times 100.'}, {'measure': "Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time", 'timeFrame': '6 months post-implant', 'description': 'The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale ranges from a minimum of 0 and a maximum of 100. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.'}, {'measure': 'Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort', 'timeFrame': 'Events occurring ≥ 31 days and up through 8 years post-implant', 'description': "A linearized rate percentage is calculated by the following equation: \\[(Total number of late adverse events in each category/total number of late patient years) x 100\\]. Late adverse events are events that occur ≥ 31 days post-implant through each subject's last follow-up visit or contact. Late patient years are calculated by totaling the amount of time the valve is implanted in the patient while participating in the trial and the count begins at ≥ 31 days post-implant through all subject's last follow-up visit or contact."}, {'measure': "Subject's Average Mean Gradient Measurement", 'timeFrame': 'Baseline and 8 years post-implant', 'description': 'Mean gradient is the average flow of blood through the mitral valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.'}, {'measure': "Subject's Average Peak Gradient Measurement", 'timeFrame': 'Baseline and 8 years post-implant', 'description': 'Peak gradient is the maximum value measured of flow of blood through the mitral valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher valve is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve.'}, {'measure': "Subject's Average Effective Orifice Area (EOA) Measurement", 'timeFrame': 'Baseline and 8 years post-implant', 'description': 'Effective orifice area represents the cross-sectional area of the blood flow downstream of the mitral valve. Effective orifice area is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size and type of valve.'}, {'measure': "Subject's Average Effective Orifice Area Index (EOAI) Measurement", 'timeFrame': 'Baseline and 8 years post-implant', 'description': "Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the mitral valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient and the size and type of valve."}, {'measure': "Subject's Average Cardiac Output Measurement", 'timeFrame': 'Baseline and 8 years post-implant', 'description': 'Cardiac output is the amount of blood the heart pumps through the circulatory system in a minute. Cardiac output is evaluated by echocardiography over time. Normal cardiac output in healthy volunteers over 60 years of age was reported between 3.1 and 6.4 liters per minute. In general, a higher value is considered better, and a lower value is considered worse.'}, {'measure': "Subject's Average Cardiac Index Measurement", 'timeFrame': 'Baseline and 8 years post-implant', 'description': "Cardiac index (CI) evaluated by echocardiography. Cardiac index is an assessment of the cardiac output value based on the patient's size. To obtain the cardiac index, divide the cardiac output by the person's body surface area (BSA). Cardiac Index is a useful marker of how well the heart is functioning as a pump by directly correlating the volume of blood pumped by the heart with an individual's body surface area. Normal cardiac output index in healthy volunteers over 60 years of age was reported between 1.1 and 3.2 L/min/m\\^2. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient."}, {'measure': "Subject's Average Left Ventricular Mass Regression", 'timeFrame': 'Baseline and 8 years post-implant', 'description': 'Patients can experience an enlargement of the left ventricle (chamber) of their heart because it works harder with a defective heart valve. Left ventricular mass regression evaluates if the patient experiences a decrease in the size of the left ventricle (chamber) after the repair or replacement of their heart valve.'}, {'measure': "Subject's Average Red Blood Cell Count", 'timeFrame': '6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits', 'description': "The red blood cell (RBC) count is a test that measures the number of oxygen-carrying blood cells in your blood. The red blood cell count normal range for women is 4.2 to 5.4 10\\^6 cells/microliters and for men is 4.7 to 6.1 10\\^6 cells/microliters. A high red blood cell count may indicate that you have a condition that's preventing you from getting enough oxygen. A low RBC may be caused by an infection, or a medical condition related to anemia. In general, results either lower or higher than the normal range may indicate something is wrong."}, {'measure': "Subject's Average White Blood Cell Count", 'timeFrame': '6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits', 'description': 'Laboratory analysis of White Blood Cell (WBC) count on blood drawn from subject; WBC fight infection. The normal reference range for WBC count is 4.5 to 10.0 10\\^3 cells/microliters. In general, results either lower or higher than the normal range can indicate something is wrong.'}, {'measure': "Subject's Average Hemoglobin Count", 'timeFrame': '6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits', 'description': 'This is the laboratory analysis of Hemoglobin count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells. In males, a healthy hemoglobin level is between 13.2 and 16.6 g/dL. In females, a hemoglobin count of between 11.6 and 15 g/dL is considered normal and healthy. In general, results either lower or higher than the normal range can indicate something is wrong.'}, {'measure': "Subject's Average Hematocrit Count", 'timeFrame': '6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits', 'description': 'This is laboratory analysis of Hematocrit percentage on blood drawn from subjects. A hematocrit test measures the proportion of red blood cells in your blood. Red blood cells carry oxygen throughout your body. Having too few or too many red blood cells can be a sign of certain diseases. Normal hematocrit ranges for adult females are 36% to 44% and for adult males are 41% to 50%. In general, results either lower or higher than the normal range can indicate something is wrong.'}, {'measure': "Subject's Average Reticulocytes Percentage Over Time", 'timeFrame': '6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits', 'description': 'Laboratory Analysis of reticulocytes on blood drawn from subjects. Reticulocytes are newly produced immature red blood cells; a reticulocyte blood test measures the amount of these cells in the blood. The reference range for reticulocytes is 0.5 - 2.6 % of red blood cells. In general, results either lower or higher than the normal range can indicate something is wrong.'}, {'measure': "Subject's Average Platelet Count Over Time", 'timeFrame': '6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits', 'description': 'This is laboratory analysis of Platelet count on blood drawn from subjects. The purpose of platelets is to create hemostasis, which is the prevention of hemorrhaging (bleeding) and the process of keeping blood inside the vessel walls. A normal platelet range is 150 to 450 10\\^3 cells/microliter. In general, results either lower or higher than the normal range can indicate something is wrong.'}, {'measure': "Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time", 'timeFrame': '6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits', 'description': "The serum lactate dehydrogenase (LDH) test looks for signs of damage to the body's tissues. Normal levels of LDH in the blood can vary depending on the lab but usually range between 140 units per liter (U/L) to 280 U/L for adults and tend to be higher for children and teens. In general, results either lower or higher than the normal range can indicate something is wrong."}, {'measure': "Subject's Average Plasma Free Hemoglobin Over Time", 'timeFrame': '6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits', 'description': 'Laboratory analysis of Plasma Free Hemoglobin (Pf Hgb) of blood drawn from subject. This blood test measures the level of free hemoglobin in the plasma (liquid portion of the blood). The reference range for plasma free hemoglobin is 0.0 to 15.2 mg/dL. In general, values higher than this can indicate something is wrong.'}, {'measure': "Subject's Average Haptoglobin Over Time", 'timeFrame': '6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits', 'description': 'Haptoglobin is a protein produced by your liver. It binds with hemoglobin, which is a protein found in red blood cells. When red blood cells are destroyed, they release hemoglobin. The released hemoglobin is called "free hemoglobin." Haptoglobin attaches to the free hemoglobin to create a haptoglobin-hemoglobin complex. This complex travels to the liver, where it\'s removed from the body. A normal haptoglobin level falls between 45 and 200 milligrams of haptoglobin per deciliter of blood. In general, results either lower or higher than the normal range can indicate something is wrong.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Mitral valve', 'pericardial bioprostheses', 'PERIMOUNT', 'bovine pericardial leaflets', 'mitral valve replacement', 'mitral valve regurgitation', 'Heart valve disease'], 'conditions': ['Coronary Artery Disease', 'Mitral Valve Regurgitation', 'Mitral Valve Incompetence', 'Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards® PERIMOUNT Magna Mitral Valves in patients undergoing mitral valve replacement with or without concomitant procedures requiring cardiopulmonary bypass.', 'detailedDescription': "This is a prospective, single-arm, multi-center study to be conducted in the US and outside the US (OUS). Approximately 250 subjects are planned to be enrolled to obtain long term data from 101 subjects at 8 years post implant of the Magna mitral valve. Of these 250, approximately 38 (15%) are anticipated to be simultaneous aortic and mitral replacements. Subject enrollment will not start in the US before obtaining FDA approval of this post market study.\n\nAssessments will be obtained for the preoperative and operative visits, and postoperatively at discharge, six months, 1-year and annually thereafter for a minimum of 8 years. Subject's demographics (date of birth, sex), physical assessment (heart rate, height, weight, systolic and diastolic blood pressures), New York Heart Association (NYHA) functional class, cardiac rhythm, cardiovascular medical history/risk factors, non-cardiovascular conditions, previous cardiovascular procedures/interventions, antithromboembolic and lipid lowering medications and coagulation profile. Blood data will be collected from each subject preoperatively, at 6 months and annually post implant through 8 year follow-ups. Echocardiographic evaluation required for each subject preoperatively, at discharge, 6 months (between 3-6 months), 1, 2, 4, 6, and 8 year follow-ups. A QOL survey (EQ-5D) will be completed by the subject pre-operatively and at the 6-month follow-up visit."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The patient requires, as indicated in the preoperative evaluation, a replacement mitral valve.\n* The patient has signed and dated the subject informed consent form prior to surgery.\n* The patient is expected to survive the surgery and be discharged.\n* The patient is geographically stable and agrees to attend follow-up assessments.\n* The patient is 18 years or older.\n\nExclusion Criteria:\n\n* The patient has any known non-cardiac life-threatening disease, which will limit the patient's life expectancy below 1 year.\n* The patient presents with active endocarditis within the last 3 months.\n* The patient is pregnant or lactating.\n* The patient is an intravenous drug abuser.\n* The patient is currently a prison inmate.\n* The patient is currently participating in a study of an investigational drug or device.\n* The patient requires replacement of a native or prosthetic tricuspid or pulmonic valve.\n* The patient requires replacement of a native or prosthetic aortic valve with a prosthesis other than a commercially available Carpentier-Edwards PERIMOUNT Valve (i.e. models 2700, 2700TFX, 2800, 2800TFX, 2900, 3000, 3000TFX, 3300TFX)\\*.\n* The patient was previously enrolled in the study.\n* The patient has had prior aortic, tricuspid and/or pulmonary valve surgery, which included implantation of a bioprosthetic valve or mechanical valve that will remain in situ."}, 'identificationModule': {'nctId': 'NCT00853632', 'briefTitle': 'Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Edwards Lifesciences'}, 'officialTitle': 'Carpentier-Edwards® Perimount Magna® Mitral Pericardial Bioprostheses Models 7000/7000 TFX and Carpentier-Edwards® Perimount Magna® Mitral Ease™ Pericardial Bioprostheses Models 7200TFX and 7300/7300TFX', 'orgStudyIdInfo': {'id': '2006-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Device - CEP Mitral Valve', 'interventionNames': ['Device: CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES']}], 'interventions': [{'name': 'CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES', 'type': 'DEVICE', 'otherNames': ['Magna Mitral 7000/7000TFX, Magna Mitral Ease 7200TFX, 7300/7300TFX'], 'description': 'Mitral valve replacement', 'armGroupLabels': ['Device - CEP Mitral Valve']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Dignity Health Research Institute', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'AdventHealth Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospital & Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '50266', 'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa Heart Medical Center', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Medical School', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Spectrum Health Hospitals', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '63131', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Missouri Baptist Medical Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore University Hospital, NY', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island Jewish Medical Center', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': 'A-1130', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Krankenhaus Hietzing', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "St. Paul's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'G1V4G5', 'city': 'Québec', 'country': 'Canada', 'facility': 'Institut Universitaire de Cardiologie et de Pneumologie de Quebec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'University Clinica Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '07740', 'city': 'Jena', 'country': 'Germany', 'facility': 'Klinikum der Friedrich Schiller University', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edwards Lifesciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}