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Early Feasibility Evaluation of the AccuCinch® Ventricular Restoration System in Patients With Heart Failure and Reduced Ejection Fraction | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

Early Feasibility Evaluation of the AccuCinch® Ventricular Restoration System in Patients With Heart Failure and Reduced Ejection Fraction

An Early Feasibility Evaluation of the AccuCinch® Ventricular Restoration System in Patients With Heart Failure and Reduced Ejection Fraction (HFrEF) - The CorCinch-HFrEF Study

NCT03533517•Ancora Heart, Inc.

View on ClinicalTrials.gov

Summary

This is a non-randomized, prospective, multi-center Early Feasibility Study to evaluate the AccuCinch® Ventricular Restoration System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF).

Detailed Description

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Study patient is at least 18-years old
•Ejection Fraction: ≥20 and ≤40%
•LV end-diastolic diameter ≥55 mm
•Symptom Status: NYHA III-IV (i.e., ambulatory)
•Treatment and compliance with optimal guideline directed medical and device-based therapies for heart failure (unless contraindicated or intolerant) for at least 3 months and stable doses for 1 month with stable defined as no more than 100% increase or 50% decrease of total daily doses.
•Patients with left bundle branch block pattern and QRS duration \>150ms are required to have a CRT device for at least 3 months
•Patients required to have an ICD are required to have ICD implant at least 1 month prior to enrollment
•Able and willing to complete all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule

Exclusion Criteria

•Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 3 months
•Mitral regurgitation grade 3 (moderate-severe) or more
•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)
•Significant RV dysfunction (TAPSE \< 14)
•Severe tricuspid regurgitation
•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
+14 more criteria

Locations (18)

University of California, San Francisco

San Francisco, California, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

University of Louisville

Louisville, Kentucky, United States

Cardiovascular Institute of the South

Houma, Louisiana, United States

Minneapolis Heart Foundation Institute

Minneapolis, Minnesota, United States

Nebraska Heart Institute / Nebraska Heart Hospital

Lincoln, Nebraska, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Mt. Sinai

New York, New York, United States

Columbia University Medical Center/NYPH

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Key Dates

Start Date

August 23, 2018

Primary Completion Date

March 26, 2021

Completion Date

February 28, 2026

Last Updated

January 30, 2025

Enrollment

ACTUAL participants

Conditions

Heart FailureCardiomyopathy, Dilated

Interventions

AccuCinch® Ventricular Restoration

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Early Feasibility Evaluation of the AccuCinch® Ventricular Restoration System in Patients With Heart Failure and Reduced Ejection Fraction

Inclusion Criteria

Exclusion Criteria

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