Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-29 @ 4:09 PM
Study NCT ID:
NCT05114850
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2021-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Prospective Multicentric Clinical Follow up of Patients After Being Treated With TricValve®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014262', 'term': 'Tricuspid Valve Insufficiency'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-02', 'studyFirstSubmitDate': '2021-10-29', 'studyFirstSubmitQcDate': '2021-10-29', 'lastUpdatePostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with readmission for HF', 'timeFrame': 'up to 12 months', 'description': 'First unplanned readmission for Heart Failure'}], 'secondaryOutcomes': [{'measure': 'All cause mortality', 'timeFrame': 'up to 30 days, up to 6 months, up to 5 years', 'description': 'Number of patients in terms of all cause mortality'}, {'measure': 'Percentage of participants with major adverse events', 'timeFrame': 'up to 12 months', 'description': 'Percentage of participants with major adverse events'}, {'measure': 'Number of participants with severe adverse events', 'timeFrame': 'up to 30 days, up to 6 months, up to 5 years', 'description': 'Number of participants with severe adverse events'}, {'measure': 'Number of patients with readmission for HF', 'timeFrame': 'up to 5 years', 'description': 'First unplanned readmission for Heart Failure'}, {'measure': 'NYHA functional class', 'timeFrame': 'up to 30 days, up to 6 months, up to 5 years', 'description': 'Change of New York Heart Association (NYHA) functional class from III or IV to a lower one'}, {'measure': 'Change in BNP/NTproBNP and diuretic dosage', 'timeFrame': 'up to 12 months', 'description': 'Change in BNP/NTproBNP and diuretic dosage before intervention after intervention'}, {'measure': 'Change of the right atrium size', 'timeFrame': 'up to 30 days, up to 6 months, up to 5 years', 'description': 'Change of the Right Atrium Size assessed by echocardiography'}, {'measure': 'Change of the free valve movement', 'timeFrame': 'up to 30 days, up to 6 months, up to 5 years', 'description': 'Change of the free valve movement assessed by echocardiography'}, {'measure': 'Valve Device Regurgitation', 'timeFrame': 'up to 30 days, up to 6 months, up to 5 years', 'description': 'Number of patients with valve device regurgitation assessed by echocardiography'}, {'measure': 'Number of alive patients', 'timeFrame': 'up to 30 days, up to 6 months, up to 5 years', 'description': 'Number of alive patients free from reintervention related to TricValve System'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiovascular disease'], 'conditions': ['Tricuspid Regurgitation', 'Tricuspid Valve Insufficiency', 'Tricuspid Insufficiency', 'Heart Failure', 'Heart Diseases', 'Heart Valve Diseases']}, 'descriptionModule': {'briefSummary': 'Retrospective prospective Multicentric clinical follow up of patients with severe tricuspid regurgitation after being treated with the TricValve® Transcatheter Bicaval Valves System.', 'detailedDescription': 'The study shall enrol subjects who were treated with the TricValve® Transcatheter Bicaval Valves System® in the Inferior Vena Cava and Superior vena cava. On compliance with the inclusion / exclusion criteria the subject will be enrolled for the observational study.\n\nThe study duration for the individual subject will be up to 5 year follow up. The follow-up should be made through pre-established periodic clinical consultations at discharge, 1 month, 6 months, 1 year follow up to 5 years after the procedure. In the consultations, routine exams such as hemogram, renal function, electrocardiogram and echocardiography in order to ascertain the bioprosthesis functioning and its hemodynamic profile are documented as per clinical routine practise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study shall enrol subjects who were treated with the TricValve® Transcatheter Bicaval Valves System® in the Inferior Vena Cava and Superior vena cava. On compliance with the inclusion / exclusion criteria the subject will be enrolled for the observational study.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Successful treatment with TricValve Transcatheter Bicaval Valves System\n* Patient/patient's authorized legal guardian gives his consent to participate in the study and signed the corresponding inform consent\n\nExclusion Criteria:\n\n* no exclusion criterion"}, 'identificationModule': {'nctId': 'NCT05114850', 'briefTitle': 'Retrospective Prospective Multicentric Clinical Follow up of Patients After Being Treated With TricValve®', 'organization': {'class': 'INDUSTRY', 'fullName': 'P+F Products + Features GmbH'}, 'officialTitle': 'TRICUS REGISTRY - Retrospective Prospective Multicentric Clinical Follow up of Patients With Severe Tricuspid Regurgitation After Being Treated With the TricValve® Transcatheter Bicaval Valves System.', 'orgStudyIdInfo': {'id': 'CTS-TRIC-003'}}, 'contactsLocationsModule': {'locations': [{'zip': '3100', 'city': 'Sankt Pölten', 'state': 'Lower Austria', 'status': 'NOT_YET_RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Julia Mascherbauer, Dr', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum St. Pölten', 'geoPoint': {'lat': 48.20762, 'lon': 15.63725}}, {'zip': '1090', 'city': 'Vienna', 'status': 'NOT_YET_RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Martin Andreas, Dr', 'role': 'CONTACT'}], 'facility': 'Medizinische Universität Wien, Department of Cardiac Surgery', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1090', 'city': 'Vienna', 'status': 'NOT_YET_RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Christian Hengstenberg, UnivProf Dr', 'role': 'CONTACT'}], 'facility': 'Medizinische Universität Wien, Universitätsklinik für Innere Medizin II', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '9300', 'city': 'Aalst', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Liesbeth Rosseel, Dr', 'role': 'CONTACT'}], 'facility': 'Department of Cardiology, Algemeen Stedelijk Ziekenhuis (ASZ)', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'zip': '79104', 'city': 'Freiburg im Breisgau', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Tilmann Schwab, MD', 'role': 'CONTACT'}], 'facility': 'RkK gGmbH im Artemed Klinikverbund Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '79189', 'city': 'Freiburg im Breisgau', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Martin Czerney, MD', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '88048', 'city': 'Friedrichshafen', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jochen Wöhrle, MD', 'role': 'CONTACT'}], 'facility': 'Klinikum Friedrichshafen', 'geoPoint': {'lat': 47.65689, 'lon': 9.47554}}, {'zip': '74078', 'city': 'Heilbronn', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Marcus Hennersdorf, MD', 'role': 'CONTACT'}], 'facility': 'SLK-Kliniken Heilbronn GmbH', 'geoPoint': {'lat': 49.13995, 'lon': 9.22054}}, {'zip': '93053', 'city': 'Regensburg', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Bernhard Unsöld, MD', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '70376', 'city': 'Stuttgart', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Phillip Nikolai, MD', 'role': 'CONTACT'}], 'facility': 'Robert-Bosch-Krankenhaus', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '71364', 'city': 'Winnenden', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'A. Jeron, MD', 'role': 'CONTACT'}], 'facility': 'Rems-Murr-Kliniken', 'geoPoint': {'lat': 48.87563, 'lon': 9.39819}}, {'city': 'Kaunas', 'status': 'NOT_YET_RECRUITING', 'country': 'Lithuania', 'contacts': [{'name': 'Rimantas Benetis, Dr', 'role': 'CONTACT'}], 'facility': 'Cardiothoracic and Vascular Surgery Clinic of Hospital of LSMUH Kaunas Klinikos', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'zip': '48960', 'city': 'Galdakao', 'state': 'Bizkaia', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jose R Rumoroso, Dr', 'role': 'CONTACT'}], 'facility': 'Hospital de Galdakao-Usansolo', 'geoPoint': {'lat': 43.23073, 'lon': -2.8429}}, {'zip': '29010', 'city': 'Málaga', 'state': 'Malaga', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jose M Hernandez, Dr', 'role': 'CONTACT'}], 'facility': 'Hospital Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '08003', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Beatriz Vaquerizo Montilla, Dr', 'role': 'CONTACT'}], 'facility': 'Parc de Salut Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Xavier Freixa Rofastes, Dr', 'role': 'CONTACT'}], 'facility': 'Hospital Clinic Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08907', 'city': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Joan Antoni Gomez, Dr', 'role': 'CONTACT'}], 'facility': 'Hospital Universitari de Bellvitge', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Xavier Suarez, Dr', 'role': 'CONTACT'}], 'facility': 'Hospital Universitari Germans Trias i Pujol', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Córdoba', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Manuel Pan Alvarez, Dr', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Reina Sofia de Córdoba', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '27003', 'city': 'Lugo', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Raymundo Ocaranza Sánchez, Dr', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Lucus Augusti', 'geoPoint': {'lat': 43.00992, 'lon': -7.55602}}, {'zip': '28222', 'city': 'Madrid', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Maria del Trigo Espinosa, Dr', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Puerta de Hierro de Majadahonda', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Luis Nombela Franco, Dr', 'role': 'CONTACT'}], 'facility': 'Hospital Clínico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Raul Moreno, Dr', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ángel Sánchez Recalde, Dr', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Oviedo', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'César Morís, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Central Asturias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'city': 'Salamanca', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ignacio Cruz, Dr', 'role': 'CONTACT'}], 'facility': 'Hospital Clínico Universitario de Salamanca', 'geoPoint': {'lat': 40.42972, 'lon': -3.67975}}, {'city': 'Valladolid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ignacio J Amat Santos, Dr', 'role': 'CONTACT'}], 'facility': 'Hospital Clínico Universitario de Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'city': 'Vigo', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Andrés Iniguez Romo, Dr', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Alvaro Cunqueiro', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}], 'centralContacts': [{'name': 'Sandra Scheidl, MSc', 'role': 'CONTACT', 'email': 'sscheidl@pfcardiovascular.com', 'phone': '+436601148208'}, {'name': 'Benjamin Reutterer, Dr', 'role': 'CONTACT', 'email': 'breutterer@pfcardiovascular.com', 'phone': '+4369917237200'}], 'overallOfficials': [{'name': 'Ignacio J Amat Santos, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clínico Universitario de Valladolid'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'P+F Products + Features GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}