New device aims to restore heart function in failing hearts

NCT ID NCT04331769

Disease control Sponsor: Ancora Heart, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a device called AccuCinch that is placed around the heart to help it pump more effectively. It is for people with heart failure and a weakened heart muscle. The goal is to see if the device improves quality of life, exercise ability, and reduces serious heart events. The study involves 400 participants and is currently on hold.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2020

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18-years or older 2. Ejection Fraction: ≥20% and ≤40% measured by transthoracic echocardiography (TTE) and assessed by an echocardiography (echo) core lab 3. LV end-diastolic diameter ≥55 mm measured by TTE and assessed by an echo core lab 4. Symptom Status: 1. NYHA III, 2. NYHA ambulatory IV, or 3. NYHA II with a heart failure hospitalization within the prior 12 months (of signing the consent) 5. Able to complete six-minute walk test with distance between 100 m and 450 m. 6. Diagnosis and treatment for heart failure should be established at least 90 days before the date of consent. Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current guidelines as standard-of-care for Heart Failure therapy, with any intolerance documented. 1. "Stable" is defined as no more than a 100% increase or a 50% decrease of total daily doses. Medication changes within this range do not require any additional waiting before the screening assessments 2. When a total daily dose increase or decrease exceeds that which is considered stable, the screening TTE and CT will be postponed 30 days after the medication change 3. When additional titration is required to optimize a subject's medication that exceeds what is considered stable, the screening TTE and CT will be postponed at least 30 days after achieving the optimal dose (provided the optimal dose remains outside of the stable parameters) 4. When a dose-for-dose equivalent change in the class of medication change is made, no additional waiting is required before the screening assessments 5. When a change in class medication change exceeds what is considered stable, OR a new class of medication is added, the screening TTE and CT will be postponed 30 days after the medication change 6. If an SGLT2 inhibitor is added to a subject's medications, the screening TTE and CT will be postponed at least 30 days after the addition 7. If an SGLT2 inhibitor dose changes per the stable definition above, no additional waiting is required before the screening assessments 8. If an SGLT2 inhibitor dose change exceeds what is considered stable, the screening TTE and CT will be postponed at least 30 days after achieving the optimal dose (provided the dose remains outside of the stable parameters) 9. When applicable, for guideline-directed device-based therapies: a CRT device must be placed \> 90 days before the screening TTE and CT, and an ICD must be placed \> 30 days before the screening TTE and CT 7. Able and willing to complete all qualifying diagnostic and functional tests, willing to accept blood product transfusion if required and agrees to comply with study follow-up schedule Exclusion Criteria: Cardiovascular 1. Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 90 days prior to consent 2. Untreated clinically significant coronary artery disease (CAD) requiring revascularization 3. Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation 4. Suboptimal ventricular anatomy or wall thickness as determined from screening echocardiography and/or CT scan 5. Heart failure on the basis other than ischemic or non-ischemic dilated cardiomyopathy (e.g., hypertrophic cardiomyopathy, amyloid cardiomyopathy, restrictive cardiomyopathy, uncorrected congenital heart disease, constrictive pericarditis) 6. Hemodynamic instability within 30 days prior to the implant defined as subject requiring inotropic support or mechanical hemodynamic support 7. Any planned cardiac surgery or interventions within the next 180 days post-randomization (including therapeutic right heart procedures) 8. Active bacterial endocarditis 9. Severe RV dysfunction assessed by right heart catheterization (RHC) and/or TTE 10. Fixed pulmonary hypertension with PA systolic pressure \>70 mmHg not responsive to vasodilator therapy 11. History of any stroke within the prior 90 days of consent or documented Modified Rankin Scale ≥ 2 disability from any prior stroke Valvular 12. Mitral regurgitation grade 3+ (moderate-severe) or 4+ (severe) 13. Untreated degenerative (primary) mitral valve disease (mild prolapse with no need for intervention is allowable) 14. Prior mitral or aortic valve replacement 15. Tricuspid regurgitation grade 4+ (severe) 16. Moderate or severe aortic valve stenosis (AVA less than 1.5 cm2 or peak velocity AV Vmax \>300 cm/sec) 17. Aortic regurgitation grade 2+ (moderate), 3+ (moderate-severe), or 4+ (severe) Procedural 18. Anatomical pathology or constraints preventing appropriate access/implant of the AccuCinch Ventricular Restoration System (e.g., femoral arteries will not support a 20F Introducer sheath) 19. Renal insufficiency (i.e., eGFR of \<25 ml/min/1.73 m2) 20. Subjects in whom anticoagulation during the procedure is contraindicated 21. Subjects in whom 90 days of antiplatelet therapy is contraindicated 22. Known allergy to nitinol, polyester, or polyethylene 23. Any prior true anaphylactic reaction to contrast agents; defined as known anaphylactoid or other non-anaphylactic allergic reactions to contrast agents that cannot be adequately pre-medicated prior to the index procedure General 24. Life expectancy \<1 year due to non-cardiac conditions 25. Currently participating in another interventional investigational study 26. Subjects on high dose steroids or immunosuppressant therapy 27. Female subjects who are pregnant, of child-bearing potential without a documented birth control method, or who are lactating

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Conditions

The condition(s) this trial relates to.

cardiomyopathy dilated cardiomyopathy heart failure systolic heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dilated cardiomyopathy Heart failure with reduced ejection fraction (hfref)

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

122 sites in 10 countries. The list below names each one and where it is.
The official record

The full official record for this study. This one lists no contact details, but it is the first place any would appear.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

A O U Policlinico G. Rodolico - San Marco

Catania, Catania, 95123, Italy
AOU Città della salute e della Scienza - Ospedale Molinette

Torino, Torino, 10126, Italy
AZ Sint-Jan-Oostende AV Campus Brugge

Bruges, Belgium
Advocate Good Samaritan Hospital

Downers Grove, Illinois, 60515, United States
Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States
Ascension Providence Hospital

Southfield, Michigan, 48075, United States
Ascension Sacred Heart

Pensacola, Florida, 32504, United States
Ascension Saint Thomas

Nashville, Tennessee, 37221, United States
Ascension Texas Cardiovascular

Austin, Texas, 78705, United States
Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States
Austin Heart

Austin, Texas, 78756, United States
Baylor College of Medicine St. Luke's Medical Center

Houston, Texas, 77020, United States
Baylor Scott & White

Plano, Texas, 75093, United States
Baylor Scott & White Research Institute

Dallas, Texas, 75226, United States
Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States
Bon Secours St Mary's Hospital

Richmond, Virginia, 23226, United States
CHU de Rennes - Hôpital Pontchaillou

Rennes, 35033, France
CJW Chippenham Medical Center

Richmond, Virginia, 23225, United States
CUMC/New York Presbyterian Hospital

New York, New York, 10032, United States
CardioVasculäres Centrum

Frankfurt, 60389, Germany
Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States
Cardiovascular Research Institute of Kansas

Wichita, Kansas, 67226, United States
Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24014, United States
Centro Cardiologico Monzino S.p.a

Milan, 20138, Italy
Charleston Area Medical Center

Charleston, West Virginia, 25304, United States
Cleveland Clinic

Cleveland, Ohio, 44195, United States
Clinique-Pasteur

Toulouse, 31300, France
Deborah Heart & Lung

Browns Mills, New Jersey, 08015, United States
Dignity Health St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States
Emory University

Atlanta, Georgia, 30308, United States
Erasmus Medical Center

Rotterdam, Netherlands
Geisinger Clinic

Danville, Pennsylvania, 17822, United States
Grandview Medical Group Research, LLC

Birmingham, Alabama, 35243, United States
HCA Florida Largo Hospital

Largo, Florida, 33770, United States
Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States
Hartford Health

Hartford, Connecticut, 06102, United States
Houston Heart

Houston, Texas, 77004, United States
Hygeia Hospital

Athens, Greece
Hôpital de la Timone

Marseille, 13005, France
INTEGRIS Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States
IRCCS Istituto Clinico Humanitas

Milan, Lombardy, 20089, Italy
Immanuel Klinikum Bernau Herzzentrum Brandenburg Universitätsklinikum der Medizinischen Hochschule Brandenburg

Bernau, 16321, Germany
Institute of Cardiovascular Diseases

Belgrade, 11000, Serbia
Institute of Cardiovascular Diseases of Vojvodina

Belgrade, 11000, Serbia
Interbalkan Medical Hospital of Thessaloniki

Thessaloniki, 57001, Greece
Intermountain Medical Center

Salt Lake City, Utah, 84109, United States
JFK Medical Center

Atlantis, Florida, 33462, United States
Jackson Heart Clinic

Jackson, Mississippi, 39216, United States
Kaiser Permanente San Francisco

San Francisco, California, 94115, United States
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Medical University of South Carolina

Charleston, South Carolina, 29425, United States
Medstar Health Research Institute

Washington D.C., District of Columbia, 20010, United States
Methodist Healthcare System, San Antonio

San Antonio, Texas, 78229, United States
Metropolitan Heart and Vascular Institute & Mercy Hosp

Coon Rapids, Minnesota, 55433, United States
Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States
Montefiore Medical Center

The Bronx, New York, 10467, United States
Mount Sinai Hospital

New York, New York, 10029, United States
NC Heart and Vascular Research, LLC

Raleigh, North Carolina, 27607, United States
NYU Langone Health

New York, New York, 10016, United States
Na Homolce Hospital

Prague, Czechia
New Mexico Heart Institute

Albuquerque, New Mexico, 87102, United States
Northern Light Eastern Maine Medical Center

Bangor, Maine, 04401, United States
Northside Hospital

Atlanta, Georgia, 30342, United States
Northwell Health

Manhasset, New York, 11030, United States
Norton Heart Specialists

Louisville, Kentucky, 40216, United States
OLV Heart Centre

Aalst, 9300, Belgium
Ohio State University

Columbus, Ohio, 43210, United States
Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73120, United States
Oklahoma Heart Institute

Tulsa, Oklahoma, 74104, United States
Onassis Cardiac Surgery Center

Kallithea, 17674, Greece
Oregon Health & Science University

Portland, Oregon, 97239, United States
Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, 70808, United States
Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States
Phoenix Cardiovascular Research Group

Phoenix, Arizona, 85016, United States
Prisma Health

Columbia, South Carolina, 29203, United States
Providence Sacred Heart Medical Center

Spokane, Washington, 99204, United States
Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States
Republican Scientific and Practical Centre of Cardiology

Minsk, 220036, Belarus
Rhode Island Hospital

Providence, Rhode Island, 02904, United States
Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States
Scripps Health

La Jolla, California, 92121, United States
Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States
Spectrum Health

Grand Rapids, Michigan, 49503, United States
St. Anne's University Hospital

Brno, 60200, Czechia
St. Antonius Ziekenhuis

Nieuwegein, Netherlands
St. Francis Hospital

Roslyn, New York, 11576, United States
Tennova Healthcare-Turkey Creek Medical Center

Knoxville, Tennessee, 37934, United States
The Christ Hospital

Cincinnati, Ohio, 45219, United States
Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States
Tucson Medical Center

Tucson, Arizona, 85712, United States
UPMC Heart and Vascular Institute

Pittsburgh, Pennsylvania, 15232, United States
UT Health

Houston, Texas, 77030, United States
University Clinical Center Niš

Niš, 18108, Serbia
University Clinical Centre of Serbia

Belgrade, 11000, Serbia
University at Buffalo

Buffalo, New York, 14203, United States
University of California Irvine Medical Center

Orange, California, 92868, United States
University of California San Diego

La Jolla, California, 92037, United States
University of California, San Francisco

San Francisco, California, 94143, United States
University of Chicago Medical Center

Chicago, Illinois, 60637, United States
University of Kansas Medical Center

Kansas City, Kansas, 66160, United States
University of Kentucky

Lexington, Kentucky, 40536, United States
University of Maryland Medical Center

Baltimore, Maryland, 21201, United States
University of Massachusetts

Worcester, Massachusetts, 01655, United States
University of Miami

Miami, Florida, 33136, United States
University of Michigan

Ann Arbor, Michigan, 48109, United States
University of Minnesota

Minneapolis, Minnesota, 55414, United States
University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States
University of South Florida

Tampa, Florida, 33606, United States
University of Southern California

Los Angeles, California, 90033, United States
University of Virginia Health System

Charlottesville, Virginia, 22908, United States
University of Washington

Seattle, Washington, 98195, United States
Universitäres Herz- und Gefäßzentrum Hamburg

Hamburg, 20246, Germany
Universitätsklinikum Halle (Saale)

Halle, 06120, Germany
Universitätsklinikum Köln (AöR)

Cologne, 50937, Germany
Valley Health Winchester

Winchester, Virginia, 22601, United States
Vanderbilt University Medical Center

Nashville, Tennessee, 87232, United States
Vassar Brothers Medical Center

Poughkeepsie, New York, 12601, United States
Washington University in St. Louis

St Louis, Missouri, 63110, United States
Weill Cornell Medicine-New York Presbyterian Hospital

New York, New York, 10065, United States
William Beaumont Hospital

Royal Oak, Michigan, 48073, United States
Yale University

New Haven, Connecticut, 06519, United States

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