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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 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04331769
The ClinicalTrials.gov registry entry for NCT04331769 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ancora Heart, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04331769 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04331769?
The interventions under investigation include: AccuCinch Ventricular Restoration System (DEVICE), Guideline-Directed Medical Therapy (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04331769?
This trial is sponsored by Ancora Heart, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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