Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-02-28 @ 3:48 AM
Study NCT ID:
NCT07188233
Status:
RECRUITING
Last Update Posted:
2025-09-23
First Post:
2025-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With FMR
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-20', 'studyFirstSubmitDate': '2025-02-28', 'studyFirstSubmitQcDate': '2025-09-20', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical Device Success (measured at the exit of the catheterization laboratory) is defined per Mitral Valve Academic Research Consortium (MVARC).', 'timeFrame': 'Periprocedural', 'description': 'Technical Device Success: MVARC Technical Success is a definition from the Mitral Valve Academic Research Consortium for evaluating transcatheter mitral valve interventions, defined at the exit from the procedure room and requires all of the following conditions to be met:\n\n1. The patient is alive.\n2. There was successful access, delivery, and retrieval of the device delivery system.\n3. The first intended device was successfully deployed and correctly positioned.\n4. There was freedom from emergency surgery or reintervention related to the device or access procedure.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mitral Valve Regurgitation (Degenerative or Functional)']}, 'descriptionModule': {'briefSummary': 'Patients with functional mitral regurgitation classified as moderate to severe (3+) or severe (4+) that are symptomatic (NYHA Class II-IV) will be evaluated for treatment using the CathHELIX Transcatheter Mitral Annuloplasty System.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate to severe (3+) or severe (4+) functional mitral regurgitation\n* Left ventricular ejection fraction ≥30%\n* Symptomatic New York Heart Association (NYHA) Class II to IV).\n\nExclusion Criteria:\n\n* Oxygen dependent for COPD\n* Active or suspected endocarditis\n* Severe symptomatic carotid stenosis\n* Has undergone heart transplantation.\n* Severe calcification of the mitral annulus or leaflets\n* Coronary sinus anatomy that may preclude proper treatment with the device'}, 'identificationModule': {'nctId': 'NCT07188233', 'acronym': 'MARCH', 'briefTitle': 'Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With FMR', 'organization': {'class': 'INDUSTRY', 'fullName': 'HVR Cardio Oy'}, 'officialTitle': 'A Study to Evaluate the Feasibility and Safety of Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With Functional Mitral Regurgitation', 'orgStudyIdInfo': {'id': 'CIP-2023-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single Arm', 'interventionNames': ['Device: Transcatheter Mitral Valve Repair']}], 'interventions': [{'name': 'Transcatheter Mitral Valve Repair', 'type': 'DEVICE', 'description': 'Mitral valve repair with the CathHELIX Transcatheter Mitral Annuloplasty System in subjects with functional Mitral Regurgitation', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tbilisi', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'Georgia', 'contacts': [{'name': 'Tamaz Shaburishvili', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tbilisi Heart and Vascular Clinic', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Vilnius', 'state': 'Lithuania', 'status': 'RECRUITING', 'country': 'Lithuania', 'contacts': [{'name': 'Giedrius Davidavičius', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vilnius University Hospital, Santaros Klinikos, Public Institution', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}], 'centralContacts': [{'name': 'Thomas Fleming', 'role': 'CONTACT', 'email': 'tom@hvrcardio.com', 'phone': '612 940 8037'}], 'overallOfficials': [{'name': 'Vinayak Bapat', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abbott Northwestern and United Hospitals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HVR Cardio Oy', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}