Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients With Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation

Heart Failure Clinical Trial

— CorCinch-PMVI  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03560167
• Other study ID #: 5018
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Heart Failure
• Mitral Valve Insufficiency

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