Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT04614402
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-02
First Post:
2020-09-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014262', 'term': 'Tricuspid Valve Insufficiency'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2020-09-25', 'studyFirstSubmitQcDate': '2020-10-28', 'lastUpdatePostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with major adverse events (MAE rates)', 'timeFrame': '30 days', 'description': 'The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days'}, {'measure': 'Change in tricuspid regurgitation severity (scale of 0-5) by echocardiography', 'timeFrame': 'Discharge: defined as discharge or 7 days post-procedure, whichever comes first', 'description': 'Reduction in TR severity as assessed by TEE pre and post-implant in the procedure room. TR severity compared to baseline will be assessed by TR grade at each follow-up interval.'}], 'secondaryOutcomes': [{'measure': 'Volume overload assessed by serial measurements', 'timeFrame': 'baseline, 30 days, 6 months, 12 months, annually up to 5 years', 'description': 'Patient edema questionnaire'}, {'measure': 'Volume overload assessed by serial measurements', 'timeFrame': 'baseline, 30 days, 6 months, 12 months, annually up to 5 years', 'description': 'Body weight in kilogram'}, {'measure': 'Volume overload assessed by serial measurements', 'timeFrame': 'baseline, 30 days, 6 months, 12 months, annually up to 5 years', 'description': 'Edema Assessment (scale 1+ - 4+) grade correspond to mm'}, {'measure': 'Volume overload assessed by serial measurements', 'timeFrame': 'baseline, 30 days, 6 months, 12 months, annually up to 5 years', 'description': 'Ankle circumference measurement in cm'}, {'measure': 'Functional class, functional status, and Quality of life as assessed', 'timeFrame': 'baseline, 30 days, 6 months, 12 months, annually up to 5 years', 'description': 'NYHA classification (I-IV) grade'}, {'measure': 'Functional class, functional status, and Quality of life as assessed', 'timeFrame': 'baseline, 30 days, 6 months, 12 months, annually up to 5 years', 'description': '6-Minute Walk Test in meter'}, {'measure': 'Functional class, functional status, and Quality of life as assessed', 'timeFrame': 'baseline, 30 days, 6 months, 12 months, annually up to 5 years', 'description': '5 Level EQ 5D Questionnaire'}, {'measure': 'Functional class, functional status, and Quality of life as assessed', 'timeFrame': 'baseline, 30 days, 6 months, 12 months, annually up to 5 years', 'description': 'Kansas City Cardiomyopathy Questionnaire'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Tricuspid Valve Insufficiency']}, 'descriptionModule': {'briefSummary': 'This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter tricuspid valve repair.', 'detailedDescription': 'The objectives of this clinical study are to collect data on the safety and effectiveness of the PASCAL System and PASCAL Precision System in improving TR, functional status, and quality of life in a post-market setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients at or over the age of 18 determined to require percutaneous reconstruction of an insufficient tricuspid valve (TR ≥ 3+) by a Heart Team who assesses patient risk and anatomic suitability for the procedure.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient is a candidate for transcatheter tricuspid valve repair as determined by a Heart Team\n2. TR grade ≥3+ (5 grade classification)\n3. Patient is eligible to receive the PASCAL device per the current approved indications for use\n\nExclusion Criteria:\n\n1. Tricuspid valve anatomic contraindications, including previous tricuspid valve replacement\n2. Severe aortic, mitral, and/or pulmonic valve stenosis and/or regurgitation\n3. Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator\n4. Any patient considered to be part of a vulnerable population'}, 'identificationModule': {'nctId': 'NCT04614402', 'acronym': 'TriCLASP', 'briefTitle': 'Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Edwards Lifesciences'}, 'officialTitle': 'Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post-Market Clinical Follow up', 'orgStudyIdInfo': {'id': '2019-11'}}, '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 tricuspid valve.'}, {'name': 'Edwards PASCAL Precision Transcatheter Valve Repair System', 'type': 'DEVICE', 'description': 'The Edwards PASCAL Precision Valve Repair System is indicated for the percutaneous reconstruction of an insufficient tricuspid valve.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Tübingen Innere Medizin III - Kardiologie und Angiologie', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '89070', 'city': 'Ulm', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Ulm Innere Medizin II', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '81377', 'city': 'München', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Medizinische Klinik I- Campus Grosshadern', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': 'D-50937', 'city': 'Cologne', 'state': 'DEU', 'country': 'Germany', 'facility': 'Herzzentrum Universitätsklinikum Köln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '45147', 'city': 'Essen', 'state': 'Nordrhine Westfalia', 'country': 'Germany', 'facility': 'Westdeutsches Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'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': '04289', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Heart Centre of the University Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '99437', 'city': 'Bad Berka', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'Zentralklinik Bad Berka GmbH', 'geoPoint': {'lat': 50.89982, 'lon': 11.28245}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'UKE Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '22087', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Kath. Marienkrankenhaus Hamburg gGmbH', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Lübeck', 'country': 'Germany', 'facility': 'University Heart Center Lübeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '151 23', 'city': 'Athens', 'country': 'Greece', 'facility': 'Hygeia Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Massa', 'country': 'Italy', 'facility': 'Ospedale del Cuore "G. Pasquinucci"', 'geoPoint': {'lat': 44.03541, 'lon': 10.13927}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Stephan Baldus, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herzzentrum Uniklinik Köln, Klinik III für lnnere Medizin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edwards Lifesciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}