Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-01-27 @ 11:17 AM
Study NCT ID:
NCT04443218
Status:
COMPLETED
Last Update Posted:
2024-07-26
First Post:
2020-04-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Edwards PASCAL Transcatheter Valve Repair System Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Feldman_Info@edwards.com', 'phone': '949-250-2500', 'title': 'Ted Feldman', 'organization': 'Edwards Lifesciences'}, 'certainAgreement': {'otherDetails': 'Publication or presentation of the overall registry results and/or site-specific results requires prior written approval of Edwards.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Interpretation of some outcome measures is limited by significant incomplete and/or missing data due to retrospective data collection, differences in data collected as part of standard of care across sites, and use of alternative follow-up data collection methods in lieu of in-person clinical visits. Additionally, this registry did not use an echocardiography core laboratory to assess echocardiography parameters or a clinical events committee to adjudicate adverse events.'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Edwards PASCAL Transcatheter Mitral Valve Repair System', 'description': 'Mitral valve repair with PASCAL implanted via transcatheter procedure', 'otherNumAtRisk': 220, 'deathsNumAtRisk': 220, 'otherNumAffected': 0, 'seriousNumAtRisk': 220, 'deathsNumAffected': 19, 'seriousNumAffected': 82}], 'seriousEvents': [{'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'STS/ACC TVT Registry'}, {'term': 'Readmission - Cardiac (not Heart Failure)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 30, 'numAffected': 26}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'STS/ACC TVT Registry'}, {'term': 'Readmission - Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 51, 'numAffected': 35}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'STS/ACC TVT Registry'}, {'term': 'Atrial Septal Defect (ASD) Closure Due to Transseptal Catheterizaton', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'STS/ACC TVT Registry'}, {'term': 'Bleeding at Access Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'STS/ACC TVT Registry'}, {'term': 'Hematoma at Access Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'STS/ACC TVT Registry'}, {'term': 'Major Vascular Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'STS/ACC TVT Registry'}, {'term': 'Other Device Related Event', 'notes': 'Includes but is not limited to Single Leaflet Device Attachment events that occurred during follow-up.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'STS/ACC TVT Registry'}, {'term': 'Single Leaflet Device Attachment', 'notes': 'Includes Single Leaflet Device Attachment events reported during procedure visit only. Single Leaflet Device Attachment events occurring during follow-up reported as Other Device Related Event.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'STS/ACC TVT Registry'}, {'term': 'New Requirement for Dialysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'STS/ACC TVT Registry'}, {'term': 'Complication Requiring Transcatheter or Surgical Intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'STS/ACC TVT Registry'}, {'term': 'Mitral Valve Re-Intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'STS/ACC TVT Registry'}, {'term': 'Readmission - Non-Cardiac (Follow Up)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 30, 'numAffected': 22}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'STS/ACC TVT Registry'}, {'term': 'Unplanned Other Cardiac Surgery or Intervention (Not Mitral Valve Re-Intervention)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 27, 'numAffected': 16}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'STS/ACC TVT Registry'}, {'term': 'Unplanned Vascular Surgery or Intervention (for Bleeding or Access Site Complication)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'STS/ACC TVT Registry'}, {'term': 'Life-Threatening Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'STS/ACC TVT Registry'}, {'term': 'Major Bleeding Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'STS/ACC TVT Registry'}, {'term': 'Other Bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'STS/ACC TVT Registry'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Major Adverse Events (MAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Edwards PASCAL Transcatheter Mitral Valve Repair System', 'description': 'Mitral valve repair with PASCAL implanted via transcatheter procedure'}], 'classes': [{'title': 'Composite MAE', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'All-cause death', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Myocardial infarction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Stroke', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Heart failure hospitalization', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Complication requiring transcatheter or surgical intervention (repeat TEER or mitral valve surgery)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Composite rate of all-cause death, myocardial infarction, stroke, heart failure hospitalization, or complication requiring transcatheter or surgical intervention (repeat transcatheter edge-to-edge repair \\[TEER\\] or mitral valve surgery)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes patients who had an MAE or who were followed for at least 30 days. Patients may experience more than one MAE.'}, {'type': 'PRIMARY', 'title': 'Mitral Regurgitation (MR) Reduction to <=2+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Edwards PASCAL Transcatheter Mitral Valve Repair System', 'description': 'Mitral valve repair with PASCAL implanted via transcatheter procedure'}], 'classes': [{'title': '30 days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days, 12 months', 'description': 'MR severity assessed by sites using a 5-grade scale: none/trace (0-1+), mild (1+), mild to moderate (2+), moderate to severe (3+), and severe (4+).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome data collected per standard of care at each investigative site and analyzed, if available. Analysis population includes participants with available data at one or more timepoints.'}, {'type': 'SECONDARY', 'title': 'Quality of Life, as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Edwards PASCAL Transcatheter Mitral Valve Repair System', 'description': 'Mitral valve repair with PASCAL implanted via transcatheter procedure'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45.3', 'spread': '19.93', 'groupId': 'OG000'}]}]}, {'title': '30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '59.1', 'spread': '20.89', 'groupId': 'OG000'}]}]}, {'title': '12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.0', 'spread': '21.83', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 30 days, 12 months', 'description': 'KCCQ is a 23-item, self-administered, validated questionnaire that quantifies physical function, symptoms, social function, self-efficacy, and quality of life for patients with heart failure. Scores range from 0 to 100 with higher scores indicating better function (100 = no symptoms, no limitations, and excellent quality of life).', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome data collected per standard of care at each investigative site and analyzed, if available. Analysis population includes participants with available data at one or more timepoints.'}, {'type': 'SECONDARY', 'title': 'Quality of Life, as Assessed by EQ-5D Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Edwards PASCAL Transcatheter Mitral Valve Repair System', 'description': 'Mitral valve repair with PASCAL implanted via transcatheter procedure'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '51.9', 'spread': '18.16', 'groupId': 'OG000'}]}]}, {'title': '30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60.6', 'spread': '17.77', 'groupId': 'OG000'}]}]}, {'title': '12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '61.6', 'spread': '20.21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 30 days, 12 months', 'description': "Patient's self-rated health on a visual analog scale (0-100 points; 0=worst health you can imagine and 100=best health you can imagine).", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome data collected per standard of care at each investigative site and analyzed, if available. Analysis population includes participants with available data at one or more timepoints.'}, {'type': 'SECONDARY', 'title': 'New York Heart Association (NYHA) Functional Classification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Edwards PASCAL Transcatheter Mitral Valve Repair System', 'description': 'Mitral valve repair with PASCAL implanted via transcatheter procedure'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Class I', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Class II', 'measurements': [{'value': '33', 'groupId': 'OG000'}]}, {'title': 'Class III', 'measurements': [{'value': '161', 'groupId': 'OG000'}]}, {'title': 'Class IV', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': '30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Class I', 'measurements': [{'value': '29', 'groupId': 'OG000'}]}, {'title': 'Class II', 'measurements': [{'value': '89', 'groupId': 'OG000'}]}, {'title': 'Class III', 'measurements': [{'value': '64', 'groupId': 'OG000'}]}, {'title': 'Class IV', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Class I', 'measurements': [{'value': '28', 'groupId': 'OG000'}]}, {'title': 'Class II', 'measurements': [{'value': '73', 'groupId': 'OG000'}]}, {'title': 'Class III', 'measurements': [{'value': '67', 'groupId': 'OG000'}]}, {'title': 'Class IV', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 30 days, 12 months', 'description': 'NYHA Functional Classification is a 4-category system commonly used by physicians to assess patient heart failure symptoms based on limitations to physical activity:\n\nClass I - No symptoms and no limitation in ordinary physical activity. Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest.\n\nClass IV - Severe limitations. Experiences symptoms even while at rest.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome data collected per standard of care at each investigative site and analyzed, if available. Analysis population includes participants with available data at one or more timepoints.'}, {'type': 'SECONDARY', 'title': '6-Minute Walk Test (6MWT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Edwards PASCAL Transcatheter Mitral Valve Repair System', 'description': 'Mitral valve repair with PASCAL implanted via transcatheter procedure'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '275.5', 'spread': '116.16', 'groupId': 'OG000'}]}]}, {'title': '30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '292.9', 'spread': '119.92', 'groupId': 'OG000'}]}]}, {'title': '12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '310.2', 'spread': '108.30', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 30 days, 12 months', 'description': '6MWT is a submaximal exercise test that measures the distance that a patient can walk on a flat surface in a period of 6 minutes.', 'unitOfMeasure': 'meter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome data collected per standard of care at each investigative site and analyzed, if available. Analysis population includes participants with available data at one or more timepoints.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Edwards PASCAL Transcatheter Mitral Valve Repair System', 'description': 'Mitral valve repair with PASCAL implanted via transcatheter procedure'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '220'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '187'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}], 'dropWithdraws': [{'type': 'Exited study for other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Edwards PASCAL Transcatheter Mitral Valve Repair System', 'description': 'Mitral valve repair with PASCAL implanted via transcatheter procedure'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '77.2', 'spread': '9.61', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '82', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '138', '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': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '26.2', 'spread': '5.15', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data unavailable for 2 patients'}, {'title': 'STS Score for Mitral Valve Repair', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4.1', 'spread': '3.11', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Society of Thoracic Surgeons (STS) Score for Mitral Valve Repair is a validated risk-prediction model for operative mortality associated with mitral valve repair surgery based on the STS Adult Cardiac Care Surgery Database. In general, an STS predicted risk score of 4%-8% is considered intermediate risk and 8% or greater is considered high risk', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data unavailable for 62 patients'}, {'title': 'EuroScore II', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7.6', 'spread': '8.20', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The European System for Cardiac Operative Risk Evaluation (EuroSCORE) II is a cardiac risk model for predicting mortality after cardiac surgery. The higher the score, the higher the risk of an adverse outcome\n\nEuroScore II risk levels are as follows:\n\nLow risk: \\<8% Moderate risk: 8-10% High risk: \\>10%', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data unavailable for 17 patients'}, {'title': 'New York Heart Association (NYHA) Functional Class', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Class I', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Class II', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'Class III', 'measurements': [{'value': '161', 'groupId': 'BG000'}]}, {'title': 'Class IV', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'NYHA Functional Classification is a 4-category system commonly used by physicians to assess patient heart failure symptoms based on limitations to physical activity:\n\nClass I - No symptoms and no limitation in ordinary physical activity. Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest.\n\nClass IV - Severe limitations. Experiences symptoms even while at rest.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data unavailable for 4 patients'}, {'title': 'Mitral Regurgitation (MR) Etiology', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Functional MR', 'measurements': [{'value': '106', 'groupId': 'BG000'}]}, {'title': 'Degenerative MR', 'measurements': [{'value': '85', 'groupId': 'BG000'}]}, {'title': 'Mixed MR', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Underlying cause of MR, includes functional, degenerative, mixed (both functional and degenerative), and other', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data unavailable for 2 patients'}, {'title': 'Mitral Regurgitation (MR) Severity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'BG000'}]}], 'categories': [{'title': 'None/Trace (0-1+)', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Mild (1+)', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Mild to Moderate (2+)', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Moderate to Severe (3+)', 'measurements': [{'value': '137', 'groupId': 'BG000'}]}, {'title': 'Severe (4+)', 'measurements': [{'value': '82', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'MR severity was assessed by sites using a 5-grade scale: none/trace (0-1+), mild (1+), mild to moderate (2+), moderate to severe (3+), and severe (4+).', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-10', 'size': 13543353, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-05-12T10:00', 'hasProtocol': True}, {'date': '2019-08-26', 'size': 457458, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-05-12T10:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-15', 'studyFirstSubmitDate': '2020-04-01', 'resultsFirstSubmitDate': '2023-05-12', 'studyFirstSubmitQcDate': '2020-06-22', 'lastUpdatePostDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-15', 'studyFirstPostDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Adverse Events (MAEs)', 'timeFrame': '30 days', 'description': 'Composite rate of all-cause death, myocardial infarction, stroke, heart failure hospitalization, or complication requiring transcatheter or surgical intervention (repeat transcatheter edge-to-edge repair \\[TEER\\] or mitral valve surgery)'}, {'measure': 'Mitral Regurgitation (MR) Reduction to <=2+', 'timeFrame': '30 days, 12 months', 'description': 'MR severity assessed by sites using a 5-grade scale: none/trace (0-1+), mild (1+), mild to moderate (2+), moderate to severe (3+), and severe (4+).'}], 'secondaryOutcomes': [{'measure': 'Quality of Life, as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Scores', 'timeFrame': 'Baseline, 30 days, 12 months', 'description': 'KCCQ is a 23-item, self-administered, validated questionnaire that quantifies physical function, symptoms, social function, self-efficacy, and quality of life for patients with heart failure. Scores range from 0 to 100 with higher scores indicating better function (100 = no symptoms, no limitations, and excellent quality of life).'}, {'measure': 'Quality of Life, as Assessed by EQ-5D Visual Analog Scale (VAS)', 'timeFrame': 'Baseline, 30 days, 12 months', 'description': "Patient's self-rated health on a visual analog scale (0-100 points; 0=worst health you can imagine and 100=best health you can imagine)."}, {'measure': 'New York Heart Association (NYHA) Functional Classification', 'timeFrame': 'Baseline, 30 days, 12 months', 'description': 'NYHA Functional Classification is a 4-category system commonly used by physicians to assess patient heart failure symptoms based on limitations to physical activity:\n\nClass I - No symptoms and no limitation in ordinary physical activity. Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest.\n\nClass IV - Severe limitations. Experiences symptoms even while at rest.'}, {'measure': '6-Minute Walk Test (6MWT)', 'timeFrame': 'Baseline, 30 days, 12 months', 'description': '6MWT is a submaximal exercise test that measures the distance that a patient can walk on a flat surface in a period of 6 minutes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mitral Valve Insufficiency']}, 'descriptionModule': {'briefSummary': 'This registry will collect prospective and retrospective clinical data on patients treated with the Edwards PASCAL Transcatheter Valve Repair System outside of the Post-Market Clinical Follow-up (PMCF) study.', 'detailedDescription': 'Patients treated per standard of care at their medical facilities and a written informed consent will be collected to allow the data to be collected. This registry intends to enroll patients under commercial usage and will serve as a mechanism to collect clinical data to further characterize the safety, performance and effectiveness of the PASCAL Transcatheter Valve Repair System.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Mitral Regurgitation eligible to receive the PASCAL device', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient signs informed consent to participate in the registry\n* Patient is intended to or has received the PASCAL device\n\nExclusion Criteria:\n\n* Patient does not consent to participate\n* Patient is part of an ongoing Edwards Pre or Post Market Clinical study for the PASCAL Transcatheter Valve Repair System.'}, 'identificationModule': {'nctId': 'NCT04443218', 'acronym': 'PASCALRegistry', 'briefTitle': 'Edwards PASCAL Transcatheter Valve Repair System Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Edwards Lifesciences'}, 'officialTitle': 'Edwards PASCAL Transcatheter Valve Repair System Registry: A Multicenter Observational Registry With the Edwards PASCAL Transcatheter Valve Repair System', 'orgStudyIdInfo': {'id': '2019-03'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Edwards PASCAL Transcatheter Valve Repair System', 'type': 'DEVICE', 'description': 'The Edwards PASCAL Valve Repair System is indicated for the percutaneous reconstruction of an insufficient mitral valve.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '81377', 'city': 'München', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'LMU Klinikum der Universität München', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '16321', 'city': 'Bernau bei Berlin', 'state': 'Brandenburg', 'country': 'Germany', 'facility': 'Immanuel Klinikum Bernau', 'geoPoint': {'lat': 52.67982, 'lon': 13.58708}}, {'zip': '35392', 'city': 'Giessen', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Universitätsklinikum Gießen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'zip': '37075', 'city': 'Göttingen', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Georg-August-Universität Göttingen, Universitätsmedizin Göttingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '50937', 'city': 'Cologne', 'state': 'Nord Rhine Westphalia', 'country': 'Germany', 'facility': 'Herzzentrum Köln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '32545', 'city': 'Bad Oeynhausen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Herz- und Diabeteszentrum NRW - Bad Oeynhausen', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'zip': '53127', 'city': 'Bonn', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Herzzentrum der Universitätsklinik Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '44137', 'city': 'Dortmund', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'St.-Johannes-Hospital Dortmund', 'geoPoint': {'lat': 51.51494, 'lon': 7.466}}, {'zip': '45138', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Elisabeth-Krankenhaus Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '55131', 'city': 'Mainz', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'Universitätsmedizin der Johannes Gutenberg Universität Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '01307', 'city': 'Dresden', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Herzzentrum Universitätsklinik Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '04289', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Heart Centre of the University Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '22087', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Kath. Marienkrankenhaus Hamburg GmbH', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Joerg Hausleiter, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MD'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edwards Lifesciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}