Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2026-01-01 @ 9:39 PM
Study NCT ID:
NCT04898335
Status:
RECRUITING
Last Update Posted:
2021-05-24
First Post:
2021-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tendyne European Experience Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-18', 'studyFirstSubmitDate': '2021-04-30', 'studyFirstSubmitQcDate': '2021-05-18', 'lastUpdatePostDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of procedural success', 'timeFrame': '30 days', 'description': 'Device success (structural and functional); absence of death, stroke, life-threatening bleeding, major vascular or cardiac structural complications, acute kidney injury, myocardial infarction, heart failure and valve-related dysfunction requiring repeat procedure'}], 'secondaryOutcomes': [{'measure': 'Rate of peri-procedural myocardial infarction', 'timeFrame': '1 day', 'description': 'Myocardial infarction during the index procedure'}, {'measure': 'Rate of conversion to open-heart surgery', 'timeFrame': '1 day', 'description': 'Conversion to open-heart surgery during the index procedure'}, {'measure': 'Rate of cardiac tamponade', 'timeFrame': '1 day', 'description': 'Cardiac Tamponade during the index procedure'}, {'measure': 'Rate of procedural mortality', 'timeFrame': '1 day', 'description': 'Death during the index procedure'}, {'measure': 'Rate of technical success (cumulative endpoint according to MVARC)', 'timeFrame': '1 day', 'description': 'Absence of procedural mortality, successful access, delivery and retrieval of the delivery system, successful deployment and positioning, freedom from emergency surgery) Device success (according to MVARC): absence of procedural mortality or stroke, proper placement and positioning, freedom from unplaned procedure related to the device or access, continued safety and performance of the device (no structural or functional failure, no technical complications, reduction of MR ≤ 2+ and mitral valve gradient \\< 5 mmHg)'}, {'measure': 'Rate of device success (cumulative endpoint according to MVARC)', 'timeFrame': '30 days, 1 year and 3 years', 'description': 'Absence of procedural mortality or stroke, proper placement and positioning, freedom from unplaned procedure related to the device or access, continued safety and performance of the device (no structural or functional failure, no technical complications, reduction of MR ≤ 2+ and mitral valve gradient \\< 5 mmHg)'}, {'measure': 'New York Heart Association (NYHA) functional class', 'timeFrame': '30 days, 1 year and 3 years', 'description': 'class I - IV'}, {'measure': '6-minute walk distance (6MWD)', 'timeFrame': '30 days, 1 year and 3 years', 'description': 'in m'}, {'measure': 'BNP/NT-proBNP level', 'timeFrame': '30 days, 1 year and 3 years', 'description': 'in pg/ml'}, {'measure': 'Mitral regurgitation severity grade', 'timeFrame': '30 days, 1 year and 3 years', 'description': 'grade 0/1+/2+/3+/4+'}, {'measure': 'Left and right ventricular dimensions', 'timeFrame': '30 days, 1 year and 3 years', 'description': 'left/right ventricular end-diastolic/-systolic diameter (in mm)'}, {'measure': 'Left ventricular function', 'timeFrame': '30 days, 1 year and 3 years', 'description': 'LVEF in percent'}, {'measure': 'Right ventricular function', 'timeFrame': '30 days, 1 year and 3 years', 'description': 'TAPSE in mm'}, {'measure': 'Pulmonary artery pressure', 'timeFrame': '30 days, 1 year and 3 years', 'description': 'in mmHg'}, {'measure': 'Tricuspid regurgitation severity grade', 'timeFrame': '30 days, 1 year and 3 years', 'description': 'grade 1-5'}, {'measure': 'Transprosthetic gradient', 'timeFrame': '30 days, 1 year and 3 years', 'description': 'in mmHg'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['mitral regurgitation', 'Tendyne', 'transcatheter mitral valve replacement'], 'conditions': ['Mitral Regurgitation']}, 'referencesModule': {'references': [{'pmid': '38385922', 'type': 'DERIVED', 'citation': 'Hell MM, Wild MG, Baldus S, Rudolph T, Treede H, Petronio AS, Modine T, Andreas M, Coisne A, Duncan A, Franco LN, Praz F, Ruge H, Conradi L, Zierer A, Anselmi A, Dumonteil N, Nickenig G, Pinon M, Barth S, Adamo M, Dubois C, Torracca L, Maisano F, Lurz P, von Bardeleben RS, Hausleiter J; TENDER Investigators. Transapical Mitral Valve Replacement: 1-Year Results of the Real-World Tendyne European Experience Registry. JACC Cardiovasc Interv. 2024 Mar 11;17(5):648-661. doi: 10.1016/j.jcin.2023.12.027. Epub 2024 Feb 21.'}]}, 'descriptionModule': {'briefSummary': 'TENDER is a multicenter, single-device, retrospective and prospective, observational study to assess safety and efficacy of the Tendyne Mitral Valve System in a real-world population.', 'detailedDescription': 'Mitral regurgitation (MR) is a common disease and is associated with high morbidity and mortality if left untreated. Due to age and comorbidities, patients are often ineligible for surgical repair or replacement. Over the last years, transcatheter systems have been introduced as an alternative therapeutic approach. The Tendyne Mitral Valve System (Abbott Vascular, Roseville, Minnesota) is a transcatheter transapical, self-expanding valve prosthesis for mitral valve replacement. A recent study has proven safety and feasibilty of the system, leading to commercial approvement (CE mark). However, data on real world experience with the system are not available.\n\nTENDER is a multicenter, single-device, retrospective and prospective, observational study. Objectives of the study are 1) to assess early outcomes, including safety and efficacy, in patients treated with the Tendyne Mitral Valve System for severe MR at 30 days, 2) to assess clinical outcomes in patients treated with the Tendyne Mitral Valve System for severe MR at 1 year and 3 year follow-up, and 3) to identify echocardiographic and CT-based anatomic predictors associated with outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive patients undergoing Implantation of Tendyne Mitral Valve System at the participating centres.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients treated with the Tendyne Mitral Valve System for mitral valve disease in a commercial setting\n* Patients providing written informed consent in compliance with the protocol, the ICH-GCP and all national legal and regulatory requirements\n\nExclusion Criteria:\n\n* Patients not providing written informed consent'}, 'identificationModule': {'nctId': 'NCT04898335', 'acronym': 'TENDER', 'briefTitle': 'Tendyne European Experience Registry', 'organization': {'class': 'OTHER', 'fullName': 'LMU Klinikum'}, 'officialTitle': 'TENDyne European expeRience Registry', 'orgStudyIdInfo': {'id': '21-0110'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tendyne', 'description': 'all patients treated with a Tendyne Mitral Valve System', 'interventionNames': ['Device: Tendyne Mitral Valve System']}], 'interventions': [{'name': 'Tendyne Mitral Valve System', 'type': 'DEVICE', 'description': 'Tendyne Mitral Valve System for mitral valve disease in a commercial setting', 'armGroupLabels': ['Tendyne']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Linz', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Andreas Zierer', 'role': 'CONTACT'}], 'facility': 'Universitaetsklinikum Linz', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Martin Andreas', 'role': 'CONTACT'}], 'facility': 'Universitaetsklinikum Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Christophe Dubois', 'role': 'CONTACT'}], 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Bordeaux', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thomas Modine', 'role': 'CONTACT'}], 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Augustin Coisine', 'role': 'CONTACT'}], 'facility': 'CHU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Rennes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christophe Leclercq', 'role': 'CONTACT'}], 'facility': 'CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nicolas Dumonteil', 'role': 'CONTACT'}], 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Bad Oeynhausen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Tanja Rudolph', 'role': 'CONTACT'}], 'facility': 'Herz- und Diabeteszentrum NRW', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Axel Unbehaun', 'role': 'CONTACT'}], 'facility': 'Deutsches Herzzentrum Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bonn', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Alexander Sedaghat', 'role': 'CONTACT'}], 'facility': 'Universitaetsklinikum Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Cologne', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Stephan Baldus', 'role': 'CONTACT'}], 'facility': 'Universitaetsklinikum Koeln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Frankfurt', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Thomas Walther', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Leonard Conradi', 'role': 'CONTACT'}], 'facility': 'UKE Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Leipzig', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Philipp Lurz', 'role': 'CONTACT'}], 'facility': 'Herzentrum Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Mainz', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Stephan von Bardeleben', 'role': 'CONTACT'}], 'facility': 'Universitätsmedizin Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'city': 'Münich', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Hendrik Ruge', 'role': 'CONTACT'}], 'facility': 'DHZ München'}, {'city': 'Regensburg', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Bernhard Unsoeld', 'role': 'CONTACT'}], 'facility': 'Universitaetsklinikum Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'city': 'Stuttgart', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Philipp Nikolai', 'role': 'CONTACT'}], 'facility': 'Robert-Bosch-Krankenhaus Stuttgart', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'city': 'Tübingen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Tobias Geisler', 'role': 'CONTACT'}], 'facility': 'Universitaetsklinikum Tuebingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Andrea Fumero', 'role': 'CONTACT'}], 'facility': 'ICH - Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Pisa', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Anna Sonia Petronio', 'role': 'CONTACT'}], 'facility': 'University Hospital of Pisa', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'city': 'Oslo', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Gry Dahle', 'role': 'CONTACT'}], 'facility': 'University hospital Oslo', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Vanessa Monivas', 'role': 'CONTACT'}], 'facility': 'Puerto de Hierro Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Luis Nombela', 'role': 'CONTACT'}], 'facility': 'University hospital Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Valladolid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ignacio Amat-Santos', 'role': 'CONTACT'}], 'facility': 'Hospital Clinico Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'city': 'Vigo', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Rodrigo Estevez-Loureiro', 'role': 'CONTACT'}], 'facility': 'University Hospital of Vigo', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'city': 'Stockholm', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Andreas Rueck', 'role': 'CONTACT'}], 'facility': 'Karolinska University Stockholm', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Basel', 'status': 'NOT_YET_RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Oliver Reuthebuch', 'role': 'CONTACT'}], 'facility': 'Universitaetsspital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'city': 'Bern', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Fabien Praz', 'role': 'CONTACT'}], 'facility': 'Inselspital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Alison Duncan', 'role': 'CONTACT'}], 'facility': 'Royal Brompton London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Joerg Hausleiter, MD', 'role': 'CONTACT', 'email': 'joerg.hausleiter@med.uni-muenchen.de', 'phone': '0049894400', 'phoneExt': '72360'}, {'name': 'Mirjam Wild, MD', 'role': 'CONTACT', 'email': 'mirjam.wild@insel.ch'}], 'overallOfficials': [{'name': 'Joerg Hausleiter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LMU Klinikum Munich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LMU Klinikum', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. Jörg Hausleiter', 'investigatorFullName': 'Prof. Dr. med. Jörg Hausleiter', 'investigatorAffiliation': 'LMU Klinikum'}}}}