The CorCinch - Functional Mitral Valve Regurgitation (FMR) Study

Heart Failure Clinical Trial

Official title:

Early Feasibility Study of the AccuCinch® Ventricular Restoration System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02806570
• Other study ID #: 4433
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2016
• Est. completion date: March 2024

Study information

• Verified date: July 2021
• Source: Ancora Heart, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multi-center, non-randomized, prospective Early Feasibility Study to evaluate the AccuCinch® Ventricular Restoration System in patients with symptomatic heart failure and concomitant functional mitral regurgitation that have stable symptoms on guideline-directed medical therapy

Description:

Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular Restoration System, FDA Approval Date 08Aug2020

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: March 2024
• Est. primary completion date: January 2020
• 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 Consortium11; and 2003 ASE Guidelines for grading mitral regurgitation10)

• Ejection Fraction: =20 to =60%

• Symptom Status: NYHA II-IV (i.e., ambulatory)

• Treatment and compliance with optimal guideline directed medical therapy for heart failure for at least 1 month

• Surgical risk: Subject is eligible for cardiac surgery (specific risk score or comorbidities should demonstrate high risk features, as determined by the Heart Team)

• Completion of 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 30 days

• Prior surgical, transcatheter, or percutaneous mitral valve intervention

• 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) or American College of Cardiology (ACC)/American Heart Association (AHA) Stage D heart failure

• Fixed pulmonary artery systolic pressure >70 mmHg

• Severe tricuspid regurgitation (per ASE guidelines and graded by the Echo Core Lab)

• 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/constraints preventing appropriate access/implant of the AccuCinch® Ventricular Restoration 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

Related Conditions & MeSH terms

• Cardiomyopathies
• Heart Failure
• Mitral Valve Insufficiency

Intervention

Device:
• Mitral valve repair

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Montefiore Medical Center	Bronx	New York
United States	University of Virginia School of Medicine	Charlottesville	Virginia
United States	The Christ Hospital	Cincinnati	Ohio
United States	Pinnacle Health Cardiovascular Institute	Harrisburg	Pennsylvania
United States	Penn State Health Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Baylor College of Medicine St. Luke's Medical Center	Houston	Texas
United States	Nebraska Heart Institute / Nebraska Heart Hospital	Lincoln	Nebraska
United States	University of Louisville	Louisville	Kentucky
United States	Minneapolis Heart Foundation Institute	Minneapolis	Minnesota
United States	Columbia University Medical Center	New York	New York
United States	NYU Langone Medical Center	New York	New York
United States	Carilion Medical Center	Roanoke	Virginia
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	Intermountain Medical Center	Salt Lake City	Utah
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	30-Day Safety	Assess 30-day safety defined as device-related or procedure-related major adverse events (MAEs).; MAE is a composite of death; myocardial infarction; emergent conversion to surgery; stroke; major cardiac structure complication; major vascular complication; and heart failure-related hospitalization.	30-day