Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT03560167
Status:
COMPLETED
Last Update Posted:
2024-08-16
First Post:
2018-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients With Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D002311', 'term': 'Cardiomyopathy, Dilated'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D000083083', 'term': 'Laminopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-01-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-14', 'studyFirstSubmitDate': '2018-06-06', 'studyFirstSubmitQcDate': '2018-06-06', 'lastUpdatePostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety measured by device-related or procedure-related major adverse events (MAEs)', 'timeFrame': '30-day', 'description': 'Device-related or procedure-related major adverse events (MAEs)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Heart Failure', 'Cardiomyopathy, Dilated']}, 'descriptionModule': {'briefSummary': 'This is a non-randomized, prospective, multi-center Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation.', 'detailedDescription': 'Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular Restoration System, FDA Approval Date August 14, 2020.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Study patient is at least 18-years old\n* Severity of FMR: ≥ Moderate (i.e., ≥2+, according to Stone et al Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 1: Clinical Trial Design Principles. A Consensus Document from the Mitral Valve Academic Research Consortium1; and 2003 ASE Guidelines for grading mitral regurgitation2)\n* Patient has had a prior surgical or percutaneous mitral repair procedure \\>3 months prior to enrollment\n* LV Ejection Fraction: ≥20 to ≤40%\n* Symptom Status: NYHA II-IV (i.e., ambulatory)\n* Prescribed appropriate guideline-directed medical therapy for heart failure for at least 3 months with stable doses of diuretics, beta-blockers and Angiotensin converting enzyme inhibitor (ACEi) or Angiotensin II Receptor Blockers (ARB) for 1 month (with stable defined as no greater than 100% increase of 50% decrease in medication doses). Treatment shall include CRT and/or ICD when indicated by guidelines.\n* Able and willing to complete all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule\n\nExclusion Criteria:\n\n* Patients with significant organic mitral valve pathology (e.g. myxomatous degeneration, mitral valve prolapse or flail leaflets)\n* Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 3 months\n* Prior surgical, transcatheter, or percutaneous mitral valve replacement\n* Untreated clinically significant coronary artery disease (CAD) requiring revascularization\n* Hemodynamic instability: Hypotension (systolic pressure \\<90 mmHg) or requirement for inotropic support or mechanical hemodynamic support\n* Any planned cardiac surgery or interventions within the next 6 months (including right heart procedures)\n* NYHA class IV (i.e., non-ambulatory)\n* Fixed pulmonary artery systolic pressure \\>70 mmHg\n* Severe tricuspid regurgitation\n* History of stroke within the prior 3 months or any prior stroke with Modified Rankin Scale ≥ 4 disability\n* Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology\n* Anatomical pathology or constraints preventing appropriate access/implant of the AccuCinch® Ventricular Repair System (e.g., femoral arteries will not support a 20F system)\n* Renal insufficiency (i.e., eGFR of \\<30ml/min/1.73m2; Stage 4 or 5 CKD)\n* Moderate or severe aortic valve stenosis or regurgitation or aortic valve prosthesis\n* Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation\n* Active bacterial endocarditis\n* Subjects in whom anticoagulation or antiplatelet therapy is contraindicated\n* Known allergy to nitinol, polyester, or polyethylene\n* Any prior true anaphylactic reaction to contrast agents; defined as known anaphylactoid or other non-anaphylactic allergic reactions to contrast agents that cannot be adequately pre-medicated prior to the index procedure.\n* Life expectancy \\< 1 year due to non-cardiac conditions\n* Currently participating in another interventional investigational study\n* Implant or revision of any rhythm management device (CRT or CRT-D) prior 3 months or implantable cardioverter defibrillator within the prior 1 month\n* Subjects on high dose steroids or immunosuppressant therapy\n* Female subjects who are pregnant, of child bearing potential without a documented birth control method, or lactating'}, 'identificationModule': {'nctId': 'NCT03560167', 'acronym': 'CorCinch-PMVI', 'briefTitle': 'Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients With Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ancora Heart, Inc.'}, 'officialTitle': 'An Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients With Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation - The CorCinch-PMVI Study', 'orgStudyIdInfo': {'id': '5018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AccuCinch® Ventricular Restoration System', 'interventionNames': ['Device: AccuCinch® Ventricular Restoration System']}], 'interventions': [{'name': 'AccuCinch® Ventricular Restoration System', 'type': 'DEVICE', 'description': 'AccuCinch® Ventricular Restoration System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation', 'armGroupLabels': ['AccuCinch® Ventricular Restoration System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Heart', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70360', 'city': 'Houma', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Cardiovascular Institute of the South', 'geoPoint': {'lat': 29.59577, 'lon': -90.71953}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis Heart Foundation Institute', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Christ Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '73120', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Heart Hospital', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '17101', 'city': 'Harrisburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'PinnacleHealth Cardiovascular Institute', 'geoPoint': {'lat': 40.2737, 'lon': -76.88442}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Health Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '78756', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin Heart', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77020', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Baylor College of Medicine St. Luke's Medical Center", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84109', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Intermountain Medical Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia School of Medicine', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '24014', 'city': 'Roanoke', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Tech Carilion School of Medicine and Research Institute', 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Medicine', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Michael Zapien, MS, CCRA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ancora Heart, Inc.'}, {'name': 'Kendra Grubb, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}, {'name': 'Guilherme Silva, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Baylor St. Luke's Medical Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ancora Heart, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}