Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-03-12 @ 6:25 AM
Study NCT ID:
NCT04818502
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2021-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2029-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-11', 'studyFirstSubmitDate': '2021-03-22', 'studyFirstSubmitQcDate': '2021-03-25', 'lastUpdatePostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Endpoint for MR Elimination at 1 Year', 'timeFrame': 'At 1 year', 'description': 'The primary endpoint MR Elimination will be assessed at one year post-procedure and is defined as original Tendyne valve remains implanted, free from surgical removal/replacement or transcatheter mitral valve implantation (valve-in-valve), and MR \\< Grade I (mild, measured by Echocardiographic Core Lab)'}], 'secondaryOutcomes': [{'measure': 'Procedure Safety (PS)', 'timeFrame': 'Day 0, at exit procedure room', 'description': 'This will be assessed at exit from the procedure room and is defined as freedom from procedural mortality, unplanned surgical or interventional procedures related to the Tendyne valve or access procedure.'}, {'measure': 'Freedom from LVOT Obstruction (LVOTO) at 30 Days', 'timeFrame': 'At Day 30', 'description': 'This will be assessed at 30 days post-procedure and is defined as mean LVOT gradient increase \\<10 mmHg from baseline (measured by the Echo Core Lab), and free of unplanned intervention for LVOTO.'}, {'measure': 'Freedom from Paravalvular Leak (PVL) at 30 Days', 'timeFrame': 'At Day 30', 'description': 'This will be assessed at 30 days post-procedure and is defined as the Tendyne prosthesis PVL ≤ mild (Grade I), as measured by the Echo Core Lab.'}, {'measure': 'Left Ventricle Reverse Remodeling at 1 Year', 'timeFrame': 'At 1 Year', 'description': 'This will be assessed at 1-year post-procedure and is defined as the proportion of survivors at one year with baseline Left Ventricle End Diastolic Volume Index (LVEDVi) \\> 96ml/m2 that experience 10% or greater reduction in LVEDVi at one year (assessed by the Echo Core lab).'}, {'measure': 'All-Cause Mortality at 30 Days', 'timeFrame': 'At Day 30', 'description': 'This will be assessed at 30 days post-procedure and is defined as the proportion of subjects who die within 30 days post-procedure for any cause.'}, {'measure': 'Long-term Device Durability (LDD) at 5 Years', 'timeFrame': 'At 5 Years', 'description': 'This will be assessed at 5 years post-procedure and is defined as original Tendyne device remains implanted, free from surgical removal/replacement or transcatheter mitral valve implantation (valve-in-valve), and free from Structural Valve Dysfunction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tendyne', 'Tendyne Mitral Valve System', 'Transcatheter', 'Mitral Regurgitation', 'Heart Valve disease', 'Mitral Valve Regurgitation', 'Mitral Insufficiency', 'Transcatheter intervention', 'Transcatheter Mitral Valve Implantation', 'Transcatheter Mitral Valve Replacement', 'Transapical Transcatheter Mitral Valve Implantation'], 'conditions': ['Mitral Valve Regurgitation']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and performance of the Tendyne™ Mitral Valve System when used as intended in a contemporary, real-world setting.', 'detailedDescription': 'The Tendyne RESOLVE-MR study (Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation) is a prospective, single arm, multi-center, PMCF study, which will be used to support the CE Mark requirement of monitoring safety and performance for any complications or issues arising in a post-market setting.\n\nThe objective of the Tendyne RESOLVE-MR study is to confirm the safety and performance of the Tendyne Mitral Valve System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation (MR) who are considered by the local heart team as eligible for a transapical transcatheter mitral valve implantation in a real-world setting. This clinical study is intended to satisfy post-market clinical follow-up requirements of CE Mark.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects of all genders from the population of patients meeting indications for a Tendyne implant as stated within the IFU. Subjects must meet all eligibility criteria and provide written informed consent.', 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient is indicated for the Tendyne Mitral Valve System per the Instructions for Use.\n2. Patient is willing and able to comply with all follow-up requirements through five years, including study-required testing, medications, and attending all follow-up visits.\n3. Patient provides written informed consent prior to any study-specific procedure.\n\nExclusion Criteria:\n\n1. Patient is in another clinical study that may impact the follow-up or results of this study.\n2. Patient is pregnant or nursing or plan to become pregnant during the study follow-up period.\n3. Patient is under the age of 18 or age of legal consent.\n4. Patient has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, may limit the subject's ability to participate in the clinical study or to comply with follow-up requirements."}, 'identificationModule': {'nctId': 'NCT04818502', 'acronym': 'RESOLVE-MR', 'briefTitle': 'Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation (RESOLVE-MR) (Tendyne™ PMCF Study)', 'orgStudyIdInfo': {'id': 'ABT-CIP-10313'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tendyne™ Mitral Valve System', 'type': 'DEVICE', 'otherNames': ['Transcatheter Mitral Valve Implantation (TMVI)'], 'description': 'Transcatheter mitral valve implantation (TMVI) using the Tendyne™ Mitral Valve System , in which a bioprosthetic valve is implanted within the native mitral valve.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Linz', 'country': 'Austria', 'facility': 'Kepler University Hospital', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Olomouc', 'country': 'Czechia', 'facility': 'University Hospital Olomouc', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'IKEM Prague', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Třinec', 'country': 'Czechia', 'facility': 'Hospital AGEL Trinec-Podlesi', 'geoPoint': {'lat': 49.67763, 'lon': 18.67078}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'Bordeaux University Hospital', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Lille', 'country': 'France', 'facility': 'CHRU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Lyon University Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Rennes', 'country': 'France', 'facility': 'Rennes University Hospital', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Bad Oeynhausen', 'country': 'Germany', 'facility': 'Heart and Diabetes Center NRW', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'German Heart Center Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bonn', 'country': 'Germany', 'facility': 'University Hospital Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Cologne', 'country': 'Germany', 'facility': 'Universitätsclinic Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'University Hospital Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'University Heart Center Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Kiel', 'country': 'Germany', 'facility': 'Universitätsklinikum Schleswig-Holstein Campus Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'city': 'Leipzig', 'country': 'Germany', 'facility': 'Leipzig Heart Center', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Mainz', 'country': 'Germany', 'facility': 'University Medical Center Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'city': 'Munich', 'country': 'Germany', 'facility': 'German Heart Center Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'city': 'München', 'country': 'Germany', 'facility': 'Ludwig-Maximilians-Universität (LMU) München / Campus Großhadern', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Robert-Bosch Krankenhaus', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Shaare Zedek Jerusalem', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Sheba Medical Centre', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'city': 'Ancona', 'country': 'Italy', 'facility': 'Lancisi Cardiovascular Center - Politechnic University of Marcher', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'city': 'Brescia', 'country': 'Italy', 'facility': 'AOU Civili Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'city': 'Pisa', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria Pisana', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'MUMC+', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Jeddah', 'country': 'Saudi Arabia', 'facility': 'King Fahad Armed Forces', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}, {'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King Fahad Medical City', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King Faisal Specialist Hospital & Research Center', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Clinico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital Basel, Clinic for Cardiac Surgery', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'city': 'Bern', 'country': 'Switzerland', 'facility': 'Insel Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Brompton Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}