Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-05 @ 3:36 PM
Study NCT ID:
NCT02722551
Status:
WITHDRAWN
Last Update Posted:
2018-01-09
First Post:
2016-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CardiAQ-Edwards™ Transcatheter Mitral Valve Replacement (TMVR) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-05', 'studyFirstSubmitDate': '2016-03-01', 'studyFirstSubmitQcDate': '2016-03-24', 'lastUpdatePostDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom from major adverse cardiac and cerebrovascular events', 'timeFrame': '30 days', 'description': 'MACCE; all-cause mortality, myocardial infarction, stroke, renal failure, and conversion to surgery per MVARC definitions'}, {'measure': 'Freedom from individual adverse events', 'timeFrame': '30 days', 'description': '% Freedom from individual adverse events'}], 'secondaryOutcomes': [{'measure': 'New York Heart Association (NYHA) functional class', 'timeFrame': '30 days, 3 months, 6 months, 12 months', 'description': 'Number of patients with improvement in NYHA class'}, {'measure': 'Six minute walk test:', 'timeFrame': '30 days, 3 months, 6 months, 12 months', 'description': 'Increase in distance (m) from baseline'}, {'measure': 'Reduction in mitral regurgitation (MR) grade:', 'timeFrame': '30 days, 3 months, 6 months, 12 months', 'description': 'Number of patients with reduction in MR grade from baseline'}, {'measure': 'Technical success', 'timeFrame': '30 days, 3 months, 6 months, 12 months', 'description': 'Technical success per MVARC criteria (%)'}, {'measure': 'Device success', 'timeFrame': '30 days, 3 months, 6 months, 12 months', 'description': 'Device success per MVARC criteria (%)'}, {'measure': 'Procedure success', 'timeFrame': '30 days, 3 months, 6 months, 12 months', 'description': 'Procedure success per MVARC criteria (%)'}, {'measure': 'Patient success', 'timeFrame': '30 days, 3 months, 6 months, 12 months', 'description': 'Patient success per MVARC criteria (%)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mitral', 'Regurgitation', 'Insufficiency', 'Degenerative', 'Functional', 'Primary', 'Secondary', 'Organic', 'Transcatheter', 'TMVR', 'TMVI', 'Heart valve', 'Mitral valve', 'Transapical', 'Transfemoral', 'Transeptal', 'Severe'], 'conditions': ['Mitral Valve Regurgitation']}, 'descriptionModule': {'briefSummary': 'Clinical study to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve', 'detailedDescription': 'The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve with transapical and transseptal delivery systems in patients with degenerative or functional/ischemic mitral regurgitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* NYHA ≥ II\n* Moderate/severe or severe mitral regurgitation\n* Prohibitive risk for open-heart surgery\n* Meets anatomical criteria\n\nExclusion Criteria:\n\n* Unsuitable anatomy\n* Need for emergent or urgent surgery\n* Prior mechanical aortic valve replacement\n* Any prior surgical or transcatheter repair (excluding balloon valvuloplasty) or replacement of the mitral valve\n* Preexisting device in the left ventricular apex\n* Clinically significant, untreated coronary artery disease\n* Limited life expectancy (\\< 12 months)\n* Active infection'}, 'identificationModule': {'nctId': 'NCT02722551', 'acronym': 'RELIEF', 'briefTitle': 'CardiAQ-Edwards™ Transcatheter Mitral Valve Replacement (TMVR) Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Edwards Lifesciences'}, 'officialTitle': 'The RELIEF Trial: REduction or eLimination of mItral rEgurgitation in Degenerative or Functional Mitral Regurgitation With the CardiAQ-Edwards™ Transcatheter Mitral Valve', 'orgStudyIdInfo': {'id': '2015-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Treatment with the CardiAQ-Edwards™ Transcatheter Mitral Valve (transapical or transseptal delivery)', 'interventionNames': ['Device: Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve']}], 'interventions': [{'name': 'Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve', 'type': 'DEVICE', 'description': 'Replacement of the mitral valve through a transcatheter approach', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "St. Paul's Hospital, University of British Columbia", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Centre Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'G1V 4G5', 'city': 'Québec', 'country': 'Canada', 'facility': 'Centre de recherche Institut Universitaire de Cardiologie et de Pneumologie de Québec (CRIUCPQ)', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Hospitalier Régional Universitaire de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '61231', 'city': 'Bad Nauheim', 'country': 'Germany', 'facility': 'Kerckhoff-Klinik GmbH', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Deutsche Herzzentrum Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Herzzentrum der UniKlinik Köln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '20146', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'University Heart Centre', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '04289', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Leipzig Herzzentrum', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '00133', 'city': 'Roma', 'country': 'Italy', 'facility': 'Universita di Roma Tor Vergata', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '3015 CE', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus Medical Centre', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'InselSpital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Lars Sondergaard', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Rigshospitalet, Copenhagen, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edwards Lifesciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}