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NCT04331769 · ClinicalTrials.gov registry record · NA

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

A NA study of Dilated Cardiomyopathy and Heart Failure With Reduced Ejection Fraction (HFrEF), sponsored by Ancora Heart.

Recruiting
Registry status
NA
Development phase
400
Enrollment target
20
Study locations

NCT04331769 is a NA study of Dilated Cardiomyopathy and Heart Failure With Reduced Ejection Fraction (HFrEF) that is actively recruiting participants, run by Ancora Heart. The registered enrollment target is 400 participants, above the 196-participant average among 6 other Dilated Cardiomyopathy trials with a reported enrollment target (104% higher). The trial reports 20 study locations across 8 states.

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The verdict

NCT04331769, a NA study of Dilated Cardiomyopathy and Heart Failure With Reduced Ejection Fraction (HFrEF), is actively recruiting participants, sponsored by Ancora Heart.

RECRUITING
Registry status
NA
Development phase
400 participants
Enrollment target
20
Study locations

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).

Interventions

  • DEVICE AccuCinch Ventricular Restoration System
  • DRUG Guideline-Directed Medical Therapy

Study Locations (20)

California

  • University of California San Diego - La Jolla
  • Scripps Health - La Jolla
  • University of Southern California - Los Angeles
  • Kaiser Permanente San Francisco - San Francisco
  • University of California, San Francisco - San Francisco

Florida

  • JFK Medical Center - Atlantis
  • HCA Florida Largo Hospital - Largo
  • University of Miami - Miami
  • Ascension Sacred Heart - Pensacola
  • University of South Florida - Tampa

Arizona

  • Dignity Health St. Joseph's Hospital and Medical Center - Phoenix
  • Phoenix Cardiovascular Research Group - Phoenix
  • Tucson Medical Center - Tucson

Alabama

  • Grandview Medical Group Research, LLC - Birmingham
  • University of Alabama at Birmingham - Birmingham

Connecticut

  • Hartford Health - Hartford
  • Yale University - New Haven

Arkansas

  • Baptist Health Heart Failure & Transplant Institute - Little Rock

Colorado

  • University of Colorado - Aurora

District of Columbia

  • Medstar Health Research Institute - Washington D.C.

Trial Details

FieldValue
Enrollment Target 400 participants
Start Date 2020-12-21
Est. Completion 2030-12-21
Phase NA

Sponsor

Ancora Heart

4 total trials

What the Registry Record Tells You About NCT04331769

The ClinicalTrials.gov registry entry for NCT04331769 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 196-participant average among 6 other Dilated Cardiomyopathy trials with a reported enrollment target (104% higher). The listed sponsor is Ancora Heart, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Dilated Cardiomyopathy appearing as the primary indexed condition, and to 2 interventions - of which AccuCinch Ventricular Restoration System is the first listed.

NCT04331769 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT04331769 about?

NCT04331769 is a clinical study titled "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". 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).

What is the current status of trial NCT04331769?

This trial is currently recruiting. It is a NA study. The enrollment target is 400 participants. The study started on 2020-12-21. Estimated completion is 2030-12-21.

What conditions does trial NCT04331769 study?

This clinical trial studies the following conditions: Dilated Cardiomyopathy, Heart Failure With Reduced Ejection Fraction (HFrEF).

What interventions are being tested in trial NCT04331769?

The interventions under investigation include: AccuCinch Ventricular Restoration System (DEVICE), Guideline-Directed Medical Therapy (DRUG).

Who is sponsoring clinical trial NCT04331769?

This trial is sponsored by Ancora Heart, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04331769 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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