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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03560167
Other study ID # 5018
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 24, 2018
Est. completion date December 30, 2024

Study information

Verified date April 2023
Source Ancora Heart, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular Restoration System, FDA Approval Date August 14, 2020.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 5
Est. completion date December 30, 2024
Est. primary completion date March 25, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Study patient is at least 18-years old - 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) - Patient has had a prior surgical or percutaneous mitral repair procedure >3 months prior to enrollment - LV Ejection Fraction: =20 to =40% - Symptom Status: NYHA II-IV (i.e., ambulatory) - 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. - Able and willing to complete all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule Exclusion Criteria: - Patients with significant organic mitral valve pathology (e.g. myxomatous degeneration, mitral valve prolapse or flail leaflets) - Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 3 months - Prior surgical, transcatheter, or percutaneous mitral valve replacement - Untreated clinically significant coronary artery disease (CAD) requiring revascularization - Hemodynamic instability: Hypotension (systolic pressure <90 mmHg) or requirement for inotropic support or mechanical hemodynamic support - Any planned cardiac surgery or interventions within the next 6 months (including right heart procedures) - NYHA class IV (i.e., non-ambulatory) - Fixed pulmonary artery systolic pressure >70 mmHg - Severe tricuspid regurgitation - History of stroke within the prior 3 months or any prior stroke with Modified Rankin Scale = 4 disability - 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 - Anatomical pathology or constraints preventing appropriate access/implant of the AccuCinch® Ventricular Repair System (e.g., femoral arteries will not support a 20F system) - Renal insufficiency (i.e., eGFR of <30ml/min/1.73m2; Stage 4 or 5 CKD) - Moderate or severe aortic valve stenosis or regurgitation or aortic valve prosthesis - Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation - Active bacterial endocarditis - Subjects in whom anticoagulation or antiplatelet therapy is contraindicated - Known allergy to nitinol, polyester, or polyethylene - 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. - Life expectancy < 1 year due to non-cardiac conditions - Currently participating in another interventional investigational study - Implant or revision of any rhythm management device (CRT or CRT-D) prior 3 months or implantable cardioverter defibrillator within the prior 1 month - Subjects on high dose steroids or immunosuppressant therapy - Female subjects who are pregnant, of child bearing potential without a documented birth control method, or lactating

Study Design


Intervention

Device:
AccuCinch® Ventricular Restoration System
AccuCinch® Ventricular Restoration System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation

Locations

Country Name City State
United States Emory University Atlanta Georgia
United States Piedmont Heart Atlanta Georgia
United States Austin Heart Austin Texas
United States University of Virginia School of Medicine Charlottesville Virginia
United States The Christ Hospital Cincinnati Ohio
United States University Hospitals Cleveland Medical Center Cleveland Ohio
United States Hackensack University Medical Center Hackensack New Jersey
United States PinnacleHealth Cardiovascular Institute Harrisburg Pennsylvania
United States Penn State Health Milton S. Hershey Medical Center Hershey Pennsylvania
United States Cardiovascular Institute of the South Houma Louisiana
United States Baylor College of Medicine St. Luke's Medical Center Houston Texas
United States University of Louisville Louisville Kentucky
United States Minneapolis Heart Foundation Institute Minneapolis Minnesota
United States Mount Sinai New York New York
United States Oklahoma Heart Hospital Oklahoma City Oklahoma
United States Virginia Tech Carilion School of Medicine and Research Institute Roanoke Virginia
United States Intermountain Medical Center Salt Lake City Utah
United States University of California, San Francisco San Francisco California
United States University of Washington Medicine Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Ancora Heart, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety measured by device-related or procedure-related major adverse events (MAEs) Device-related or procedure-related major adverse events (MAEs) 30-day
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