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RECRUITING
NCT04331769
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

Sponsor: Ancora Heart, Inc.

View on ClinicalTrials.gov

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).

Official title: Randomized 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2020-12-21

Completion Date

2030-12-21

Last Updated

2025-12-11

Healthy Volunteers

No

Interventions

DEVICE

AccuCinch Ventricular Restoration System

AccuCinch Ventricular Restoration System

DRUG

Guideline-Directed Medical Therapy

Guideline-Directed Medical Therapy

Locations (132)

Grandview Medical Group Research, LLC

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

Dignity Health St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Phoenix Cardiovascular Research Group

Phoenix, Arizona, United States

Tucson Medical Center

Tucson, Arizona, United States

Baptist Health Heart Failure & Transplant Institute

Little Rock, Arkansas, United States

University of California San Diego

La Jolla, California, United States

Scripps Health

La Jolla, California, United States

University of Southern California

Los Angeles, California, United States

Kaiser Permanente San Francisco

San Francisco, California, United States

University of California, San Francisco

San Francisco, California, United States

University of Colorado

Aurora, Colorado, United States

Hartford Health

Hartford, Connecticut, United States

Yale University

New Haven, Connecticut, United States

Medstar Health Research Institute

Washington D.C., District of Columbia, United States

JFK Medical Center

Atlantis, Florida, United States

HCA Florida Largo Hospital

Largo, Florida, United States

University of Miami

Miami, Florida, United States

Ascension Sacred Heart

Pensacola, Florida, United States

University of South Florida

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

Piedmont Heart Institute

Atlanta, Georgia, United States

Northside Hospital

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Advocate Good Samaritan Hospital

Downers Grove, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Cardiovascular Research Institute of Kansas

Wichita, Kansas, United States

University of Kentucky

Lexington, Kentucky, United States

University of Kentucky

Lexington, Kentucky, United States

Norton Heart Specialists

Louisville, Kentucky, United States

Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, United States

Cardiovascular Institute of the South

Houma, Louisiana, United States

Northern Light Eastern Maine Medical Center

Bangor, Maine, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University of Massachusetts

Worcester, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Spectrum Health

Grand Rapids, Michigan, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

Ascension Providence Hospital

Southfield, Michigan, United States

Metropolitan Heart and Vascular Institute & Mercy Hosp

Coon Rapids, Minnesota, United States

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

University of Minnesota

Minneapolis, Minnesota, United States

Jackson Heart Clinic

Jackson, Mississippi, United States

Washington University in St. Louis

St Louis, Missouri, United States

Deborah Heart & Lung

Browns Mills, New Jersey, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Morristown Medical Center

Morristown, New Jersey, United States

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

New Mexico Heart Institute

Albuquerque, New Mexico, United States

University at Buffalo

Buffalo, New York, United States

Northwell Health

Manhasset, New York, United States

NYU Langone Health

New York, New York, United States

Mount Sinai Hospital

New York, New York, United States

CUMC/New York Presbyterian Hospital

New York, New York, United States

Weill Cornell Medicine-New York Presbyterian Hospital

New York, New York, United States

Vassar Brothers Medical Center

Poughkeepsie, New York, United States

St. Francis Hospital

Roslyn, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

NC Heart and Vascular Research, LLC

Raleigh, North Carolina, United States

The Christ Hospital

Cincinnati, Ohio, United States

UH Cleveland Medical Center

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

INTEGRIS Baptist Medical Center

Oklahoma City, Oklahoma, United States

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, United States

Oklahoma Heart Institute

Tulsa, Oklahoma, United States

Providence St. Vincent Medical Center

Portland, Oregon, United States

Oregon Health & Science University

Portland, Oregon, United States

Geisinger Clinic

Danville, Pennsylvania, United States

Pinnacle Health Cardiovascular Institute

Harrisburg, Pennsylvania, United States

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

UPMC Heart and Vascular Institute

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Prisma Health

Columbia, South Carolina, United States

Tennova Healthcare-Turkey Creek Medical Center

Knoxville, Tennessee, United States

Ascension Saint Thomas

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Ascension Texas Cardiovascular

Austin, Texas, United States

Austin Heart

Austin, Texas, United States

Baylor Scott & White Research Institute

Dallas, Texas, United States

Houston Heart

Houston, Texas, United States

Baylor College of Medicine St. Luke's Medical Center

Houston, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

UT Health

Houston, Texas, United States

Texas Tech University Health Sciences Center

Lubbock, Texas, United States

Baylor Scott & White

Plano, Texas, United States

Methodist Healthcare System, San Antonio

San Antonio, Texas, United States

Intermountain Medical Center

Salt Lake City, Utah, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

CJW Chippenham Medical Center

Richmond, Virginia, United States

Bon Secours St Mary's Hospital

Richmond, Virginia, United States

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, United States

Valley Health Winchester

Winchester, Virginia, United States

University of Washington

Seattle, Washington, United States

Providence Sacred Heart Medical Center

Spokane, Washington, United States

Charleston Area Medical Center

Charleston, West Virginia, United States

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Republican Scientific and Practical Centre of Cardiology

Minsk, Belarus

OLV Heart Centre

Aalst, Belgium

AZ Sint-Jan-Oostende AV Campus Brugge

Bruges, Belgium

St. Anne's University Hospital

Brno, Czechia

Na Homolce Hospital

Prague, Czechia

Hôpital de la Timone

Marseille, France

CHU de Rennes - Hôpital Pontchaillou

Rennes, France

Clinique-Pasteur

Toulouse, France

Immanuel Klinikum Bernau Herzzentrum Brandenburg Universitätsklinikum der Medizinischen Hochschule Brandenburg

Bernau, Germany

Universitätsklinikum Köln (AöR)

Cologne, Germany

CardioVasculäres Centrum

Frankfurt, Germany

Universitätsklinikum Halle (Saale)

Halle, Germany

Universitäres Herz- und Gefäßzentrum Hamburg

Hamburg, Germany

Hygeia Hospital

Athens, Greece

Onassis Cardiac Surgery Center

Kallithea, Greece

Interbalkan Medical Hospital of Thessaloniki

Thessaloniki, Greece

A O U Policlinico G. Rodolico - San Marco

Catania, Catania, Italy

IRCCS Istituto Clinico Humanitas

Milan, Lombardy, Italy

AOU Città della salute e della Scienza - Ospedale Molinette

Torino, Torino, Italy

Centro Cardiologico Monzino S.p.a

Milan, Italy

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Erasmus Medical Center

Rotterdam, Netherlands

Institute of Cardiovascular Diseases of Vojvodina

Belgrade, Serbia

Institute of Cardiovascular Diseases

Belgrade, Serbia

University Clinical Centre of Serbia

Belgrade, Serbia

University Clinical Center Niš

Niš, Serbia