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Evaluate the Safety and Performance of the AccuCinch® Ventricular Repair System - The CorCinch-EU Study

NCT03183895 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2025-01-29

No results posted yet for this study

Summary

This is prospective, non-randomized, single-arm, international, multicenter, clinical safety and performance clinical investigation to evaluate the AccuCinch® Ventricular Repair System for the treatment of heart failure, with or without functional mitral regurgitation due to dilated ischemic or non-ischemic cardiomyopathy

Conditions

Interventions

DEVICE

Left ventricular restoration

The AccuCinch® Ventricular Repair System, implanted in the sub-valvular space of the left ventricle, is intended to reduce significant symptomatic mitral regurgitation and reverse left ventricular remodeling due to dilated cardiomyopathy of either ischemic or non-ischemic etiology via percutaneous interventional methods.

Sponsors & Collaborators

  • Ancora Heart, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Zapien, MS, CCRA · Ancora Heart, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-15
Primary Completion
2026-10-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • Belarus
  • Belgium
  • Czechia
  • France
  • Italy
  • Lithuania
  • Netherlands
  • Poland
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT03183895 on ClinicalTrials.gov