Ignite Creation Date:
2025-12-25 @ 4:47 AM
Ignite Modification Date:
2025-12-26 @ 3:49 AM
Study NCT ID:
NCT01051518
Status:
COMPLETED
Last Update Posted:
2019-02-19
First Post:
2010-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of Percutaneous Implantation of the Medtronic CoreValve Aortic Valve Prosthesis (18Fr-Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'maarten.hollander@medtronic.com', 'phone': '+31620534428', 'title': 'M. Hollander', 'organization': 'Medtronic'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were reported from date of implantation till 4 years follow up', 'eventGroups': [{'id': 'EG000', 'title': 'High Risk', 'description': 'Overall study population was divided in high and moderate risk groups based on the risk of operative mortality. The risk classification was performed by 2 independent cardiovascular surgeons who were blinded to procedural details and outcomes but were provided with the baseline logistic EuroSCORE, baseline data and available source documentation.', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 64, 'seriousNumAtRisk': 72, 'deathsNumAffected': 47, 'seriousNumAffected': 68}, {'id': 'EG001', 'title': 'Moderate Risk', 'description': 'Overall study population was divided in high and moderate risk groups based on the risk of operative mortality. The risk classification was performed by 2 independent cardiovascular surgeons who were blinded to procedural details and outcomes but were provided with the baseline logistic EuroSCORE, baseline data and available source documentation.', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 47, 'seriousNumAtRisk': 54, 'deathsNumAffected': 20, 'seriousNumAffected': 46}], 'otherEvents': [{'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 40, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 29, 'numAffected': 19}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 21, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 32, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 26, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 14, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 23, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 18, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 32, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 81, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 49, 'numAffected': 34}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'notes': 'Any other reported adverse events not assosiated with the use of the study device were collected without specyfying a specific adverse event term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 36, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Composite Major Adverse Event (MAE) Free Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk', 'description': 'Subjects with a high risk of operative mortality.'}, {'id': 'OG001', 'title': 'Moderate Risk', 'description': 'Subjects with a moderate risk of operative mortality.'}, {'id': 'OG002', 'title': 'Overall Study', 'description': 'All enrolled subjects for whom the procedure for percutaneous implantation of the Medtronic CoreValve aortic valve prosthesis was started.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.2', 'groupId': 'OG000', 'lowerLimit': '42.0', 'upperLimit': '66.0'}, {'value': '48.1', 'groupId': 'OG001', 'lowerLimit': '34.3', 'upperLimit': '62.2'}, {'value': '51.6', 'groupId': 'OG002', 'lowerLimit': '42.5', 'upperLimit': '60.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 (+7) days post procedure', 'description': 'Percentage of subjects without a composite major adverse event (MAE) at 30 (+ 7) days post-procedure. MAE included all-cause death, non-fatal myocardial infarction, stroke, emergent cardiac re-intervention, cardiac tamponade, non-structural or structural valve dysfunction, cardiogenic shock, endocarditis, TIA, embolism, aortic dissection, access site vessel dissection, vessel perforation, acute vessel occlusion, major bleeding and major vascular injury.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Composite Technical Device Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk With Complete Device Success Data', 'description': 'Subjects with a high risk of operative mortality with all data available to calculate the composite technical device success'}, {'id': 'OG001', 'title': 'Moderate Risk With Complete Device Success Data', 'description': 'Subjects with a moderate risk of operative mortality with all data available to calculate the composite technical device success'}, {'id': 'OG002', 'title': 'Overall Study', 'description': 'All enrolled subjects for whom the procedure for percutaneous implantation of the Medtronic CoreValve aortic valve prosthesis was started.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.7', 'groupId': 'OG000', 'lowerLimit': '74.3', 'upperLimit': '92.1'}, {'value': '80.8', 'groupId': 'OG001', 'lowerLimit': '67.5', 'upperLimit': '90.4'}, {'value': '83.1', 'groupId': 'OG002', 'lowerLimit': '75.3', 'upperLimit': '89.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Was assessed during the procedure and completed once the procedure was conlcluded', 'description': 'Composite technical success was defined as the percentage of subjects in whom success on all four technical measures of the "Device Functionality Assessment" was achieved and who were adjudicated as having no device failure or malfunction.\n\nThe four measures of the \'\'Device Functionality Assessment\'\' were:\n\n* Load the valve delivery system using the loading system\n* Access the aortic valve with the delivery catheter\n* Deploy the valve accurately across the native aortic valve\n* Remove the intact delivery system', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For two patients in the moderate risk group the composite technical device success could not be calculated because not all measurements required were available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overall Study', 'description': 'All enrolled subjects for whom the procedure of percutaneous implantation of the Medtronic CoreValve aortic valve prosthesis was started.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '126'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}]}]}], 'recruitmentDetails': 'Nine sites from Western Europe and Canada enrolled 126 subjects between May 2006 and November 2008.', 'preAssignmentDetails': 'Of 126 subjects enrolled, 124 were implanted with the CoreValve aortic valve.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'High Risk', 'description': 'Subjects with a high risk of operative mortality.'}, {'id': 'BG001', 'title': 'Moderate Risk', 'description': 'Subjects with a moderate risk of operative mortality.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '81.3', 'spread': '7.2', 'groupId': 'BG000'}, {'value': '83.8', 'spread': '4.9', 'groupId': 'BG001'}, {'value': '82.4', 'spread': '6.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'EuroSCORE', 'classes': [{'categories': [{'measurements': [{'value': '28.9', 'spread': '14.5', 'groupId': 'BG000'}, {'value': '16.1', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '23.4', 'spread': '13.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measure Description: EuroSCORE: European System for Cardiac Operative Risk Evaluation. Is a measure for predicted operative mortality for patients undergoing cardiac surgery. If a risk factor is present, a weight/number is assigned. The weights are added to give an approximate percent of predicted mortality. The resulting scores are provided on a scale ranging from 0% (no risk at all) to 100% (inoperable) .', 'unitOfMeasure': 'Percent of predicted operative mortality', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'NYHA', 'classes': [{'categories': [{'title': 'NYHA class I', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'NYHA class II', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'NYHA class III', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': 'NYHA class IV', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'New York Heart Association (NYHA): I) No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea. II) Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea. III) Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. IV) Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Overall study population was divided in high and moderate risk groups based on the risk of operative mortality. The risk classification was performed by 2 independent cardiovascular surgeons who were blinded to procedural details and outcomes but were provided with the baseline logistic EuroSCORE, baseline data and available source documentation.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-18', 'studyFirstSubmitDate': '2010-01-15', 'resultsFirstSubmitDate': '2017-10-27', 'studyFirstSubmitQcDate': '2010-01-15', 'lastUpdatePostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-18', 'studyFirstPostDateStruct': {'date': '2010-01-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite Major Adverse Event (MAE) Free Rate', 'timeFrame': '30 (+7) days post procedure', 'description': 'Percentage of subjects without a composite major adverse event (MAE) at 30 (+ 7) days post-procedure. MAE included all-cause death, non-fatal myocardial infarction, stroke, emergent cardiac re-intervention, cardiac tamponade, non-structural or structural valve dysfunction, cardiogenic shock, endocarditis, TIA, embolism, aortic dissection, access site vessel dissection, vessel perforation, acute vessel occlusion, major bleeding and major vascular injury.'}], 'secondaryOutcomes': [{'measure': 'Composite Technical Device Success', 'timeFrame': 'Was assessed during the procedure and completed once the procedure was conlcluded', 'description': 'Composite technical success was defined as the percentage of subjects in whom success on all four technical measures of the "Device Functionality Assessment" was achieved and who were adjudicated as having no device failure or malfunction.\n\nThe four measures of the \'\'Device Functionality Assessment\'\' were:\n\n* Load the valve delivery system using the loading system\n* Access the aortic valve with the delivery catheter\n* Deploy the valve accurately across the native aortic valve\n* Remove the intact delivery system'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Aortic Valve Stenosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.medtronic.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The investigation concerns a prospective, multicenter, single arm safety and performance study evaluating the Medtronic CoreValve system. Approximately 120 patients presenting with symptomatic aortic native valve stenosis necessitating valve replacement which are considered poor surgical candidates, with a high surgical risk, as attested to by both the surgeon and the cardiologist are recruited in the study.\n\nSafety and performance will be evaluated at discharge and at 30 days post-procedure. Valve performance and placement will be followed up at 3 and 6 months post-procedure. Further long-term patient follow-up visits will be performed at 12, 24, 36 and 48 months post-procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Native aortic valve disease, defined as valve stenosis with an aortic valve area \\<1cm² (\\<0.6cm2/m2) as determined by echocardiographic measure,\n* ≥ 75 years, or\n* Surgical risk calculated with logistic EuroSCORE ≥ 15 %, or\n* One or two (but not more than 2) of the following complicating factors:\n\n 1. Cirrhosis of the liver (Child class A or B),\n 2. Pulmonary insufficiency : Forced expiratory volume in one second (FEV1) \\< 1 liter,\n 3. Previous cardiac surgery (Coronary artery bypass grafting (CABG), valvular surgery),\n 4. Pulmonary hypertension \\> 60 mmHg and high risk of cardiac surgery other than valve replacement,\n 5. Porcelain aorta\n 6. Recurrent pulmonary embolus,\n 7. Right ventricular insufficiency,\n 8. Thoracic burning sequelae contraindicating open chest surgery,\n 9. History of mediastinum radiotherapy,\n 10. Severe connective tissue disease resulting in a contraindication to surgery,\n 11. Cachexia (BMI ≤ 18 kg/m²),\n* Aortic valve annulus diameter is ≥ 20 mm and ≤ 27 mm as determined by echocardiographic measure,\n* Ascending aorta diameter £ 45 mm at the sino-tubular junction, and\n* Signed Informed Consent.\n\nExclusion Criteria:\n\n* Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, Nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated,\n* Any sepsis, including active endocarditis,\n* Recent myocardial infarction (\\< 30 days),\n* Percutaneous coronary or vascular intervention within 15 days prior to the study procedure, or scheduled during or within 30 days after the study procedure,\n* Any left ventricular or atrial thrombus diagnosed by echocardiography,\n* Uncontrolled atrial fibrillation (heart rate greater than 100 bpm),\n* Mitral or tricuspid valvular insufficiency ( \\> grade II),\n* Previous aortic valve replacement (mechanical valve OR stented bioprosthetic valve),\n* Any condition considered as contraindication for extracorporeal assistance,\n* Evolutive or recent CVA (cerebro vascular accident),\n* Poly arterial patients with either:\n\n 1. Femoral, iliac or aortic vascular condition (e.g. stenosis, tortuosity), that make insertion and endovascular access to the aortic valve impossible, or\n 2. Symptomatic carotid or vertebral arteries narrowing (\\> 70%) disease, or\n 3. Abdominal or thoracic aortic aneurysm,\n* Bleeding diathesis or coagulopathy, or patient who will refuse blood transfusion,\n* Evolutive disease with life expectancy less than one year,\n* Creatinine clearance \\< 20 ml/min,\n* Pregnancy, and\n* Enrolled in another investigational study.'}, 'identificationModule': {'nctId': 'NCT01051518', 'briefTitle': 'Clinical Evaluation of Percutaneous Implantation of the Medtronic CoreValve Aortic Valve Prosthesis (18Fr-Study)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiovascular'}, 'officialTitle': 'Clinical Evaluation of Percutaneous Implantation of the CoreValve Aortic Valve Prosthesis. Safety and Performance Study on Patients at High Risk for Surgical Valve Replacement (18Fr Safety and Efficacy Study)', 'orgStudyIdInfo': {'id': 'COR-2006-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CoreValve', 'interventionNames': ['Device: Medtronic CoreValve System']}], 'interventions': [{'name': 'Medtronic CoreValve System', 'type': 'DEVICE', 'otherNames': ['Medtronic CoreValve Trancatheter Aortic Valve', 'Medtronic CoreValve Percutaneous Aortic Valve'], 'description': 'Transcatheter Aortic Valve', 'armGroupLabels': ['CoreValve']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Edmonton', 'country': 'Canada', 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Montreal', 'country': 'Canada', 'facility': 'Institut de Cardiologie de Montreal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Ottawa', 'country': 'Canada', 'facility': 'University of Ottawa Heart Institute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Leipzig', 'country': 'Germany', 'facility': 'Herzzentrum Leipzig GmbH', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Siegburg', 'country': 'Germany', 'facility': 'HELIOS Heart Center Siegburg', 'geoPoint': {'lat': 50.80019, 'lon': 7.20769}}, {'city': 'Breda', 'country': 'Netherlands', 'facility': 'Amphia Hospital', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'Glenfield Hospital', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Brompton & Harefield NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'E. Grube, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helios Heart Center Siegburg, Germany'}, {'name': 'G. Schuler, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herzzentrum Universitat Leipzig, Germany'}, {'name': 'R. Bonan, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut de Cardiologie de Montreal, Canada'}, {'name': 'J. Kovac, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Glenfield Hospital Leicester, UK'}, {'name': 'P. Serruys, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus MC Rotterdam, Netherlands'}, {'name': 'M. Labinaz, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ottawa Heart Institute, Canada'}, {'name': 'P den Heijer, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amphia Hospital Breda, Netherlands'}, {'name': 'M Mullen, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Brompton & Harefield NHS Trust London, UK'}, {'name': 'W. Tymchak, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta Hospital, Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}