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Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study

NCT04331769 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-12-11

No results posted yet for this study

Summary

Prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF).

Conditions

  • Heart Failure With Reduced Ejection Fraction (HFrEF)
  • Dilated Cardiomyopathy

Interventions

DEVICE

AccuCinch Ventricular Restoration System

AccuCinch Ventricular Restoration System

DRUG

Guideline-Directed Medical Therapy

Guideline-Directed Medical Therapy

Sponsors & Collaborators

  • Ancora Heart, Inc.

    lead INDUSTRY

Principal Investigators

  • Martin B Leon, MD · Columbia University

  • Ulrich P Jorde, MD · Montefiore Medical Center/Albert Einstein College of Medicine

  • Shmuel Chen, MD · New York Presbyterian/Weill Cornell Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-21
Primary Completion
2026-12-31
Completion
2030-12-21
FDA Device
Yes

Countries

  • United States
  • Belarus
  • Belgium
  • Czechia
  • France
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Serbia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04331769 on ClinicalTrials.gov