Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT05486832
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2022-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Performance of the Cardiovalve TR Replacement System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014262', 'term': 'Tricuspid Valve Insufficiency'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'prospective, single arm, open label, multi center'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-06', 'studyFirstSubmitDate': '2022-08-02', 'studyFirstSubmitQcDate': '2022-08-02', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom from device or procedure-related adverse events', 'timeFrame': '30 days', 'description': 'Freedom from device or procedure-related adverse events'}, {'measure': 'Reduction in TR grade', 'timeFrame': '30 days', 'description': 'Reduction in TR in comparison to baseline'}], 'secondaryOutcomes': [{'measure': 'Six minute walk test', 'timeFrame': '30 days, 6 months, 12 months, annual for five years', 'description': 'Change in Six minute walk distance from Baseline'}, {'measure': 'KCCQ', 'timeFrame': '30 days, 6 months, 12 months, annual for five years', 'description': 'Change in health status from Baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tricuspid valve', 'Heart valve', 'Cardiovascular disease'], 'conditions': ['Tricuspid Regurgitation']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the safety and performance of Cardiovalve TR system', 'detailedDescription': 'The study is a multi-center, prospective, single arm study designed to evaluate the safety and performance of the Cardiovalve Tricuspid Valve Replacement System'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Functional TR ≥3+\n* Symptomatic, NYHA Class II-IVa\n* Patient approved by the Subject Screening Committee\n\nExclusion Criteria:\n\n* Cardiac anatomy deemed not suitable for the Cardiovalve TR system\n* Hemodynamic instability\n* Severe right ventricular failure\n* Refractory heart failure requiring advanced intervention'}, 'identificationModule': {'nctId': 'NCT05486832', 'acronym': 'TARGET', 'briefTitle': 'Safety and Performance of the Cardiovalve TR Replacement System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cardiovalve Ltd.'}, 'officialTitle': 'Safety and Performance of the Cardiovalve TR Replacement System for Tricuspid Regurgitation', 'orgStudyIdInfo': {'id': 'CP-21-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cardiovalve TR replacement Group', 'description': 'Cardiovalve TR valve replacement System', 'interventionNames': ['Device: Cardiovalve TR valve replacement System']}], 'interventions': [{'name': 'Cardiovalve TR valve replacement System', 'type': 'DEVICE', 'description': 'The Cardiovalve system includes a valve and delivery system, designed for replacement of the tricuspid valve through a transcatheter.', 'armGroupLabels': ['Cardiovalve TR replacement Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32545', 'city': 'Bad Oeynhausen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Rudolph Volker, MD', 'role': 'CONTACT'}], 'facility': 'Universität Bochum', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'zip': '10117', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Sherif Mohammad, MD', 'role': 'CONTACT'}], 'facility': 'Charité university', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '53127', 'city': 'Bonn', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Georg Nickenig, MD', 'role': 'CONTACT'}], 'facility': 'Uniklinik Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '50937', 'city': 'Cologne', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Adam Matti, MD', 'role': 'CONTACT'}], 'facility': 'Herzzentrum Uniklinik', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '20251', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Niklas Schofer, MD', 'role': 'CONTACT'}], 'facility': 'Universitäres Herz', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '20251', 'city': 'Lübeck', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christian. Frerker, MD', 'role': 'CONTACT'}], 'facility': 'University Heart Center Lübeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '93053', 'city': 'Regensburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Michael Hilker, MD', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum - Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}], 'centralContacts': [{'name': 'Nitza Shoham, PhD', 'role': 'CONTACT', 'email': 'nitza@cardiovalve.com', 'phone': '+972546882988'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardiovalve Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}