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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: Recruiting NA study of Dilated Cardiomyopathy and Heart Failure With Reduced Ejection Fraction (HFrEF), sponsored by Ancora Heart.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2020-12-21 |
| Est. Completion | 2030-12-21 |
| Phase | NA |
What NCT04331769 shows while recruiting
NCT04331769 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, above the 196-participant average among 6 other Dilated Cardiomyopathy trials with a reported enrollment target (104% higher).
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 names 20 study sites across 8 states, led by 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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