Heart Failure With Reduced Ejection Fraction (HFrEF)NCT04331769
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 study testing AccuCinch Ventricular Restoration System and Guideline-Directed Medical Therapy in people with Heart Failure With Reduced Ejection Fraction (HFrEF) and Dilated Cardiomyopathy, run by Ancora Heart, Inc. at 122 sites in 10 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction (HFrEF), Dilated Cardiomyopathy
- What is being tested?
- AccuCinch Ventricular Restoration System and Guideline-Directed Medical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 122 sitesin 10 countries
- Study dates
- 21 Dec 2020to 21 Dec 2030
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-years or older
- Ejection Fraction: ≥20% and ≤40% measured by transthoracic echocardiography (TTE) and assessed by an echocardiography (echo) core lab
- LV end-diastolic diameter ≥55 mm measured by TTE and assessed by an echo core lab
- Symptom Status:
- NYHA III,
- NYHA ambulatory IV, or
Show all 19Show fewer
- NYHA II with a heart failure hospitalization within the prior 12 months (of signing the consent)
- Able to complete six-minute walk test with distance between 100 m and 450 m.
- 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.
- "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
- 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
- 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)
- When a dose-for-dose equivalent change in the class of medication change is made, no additional waiting is required before the screening assessments
- 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
- 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
- If an SGLT2 inhibitor dose changes per the stable definition above, no additional waiting is required before the screening assessments
- 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)
- 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
- 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
Who cannot join
- Cardiovascular
- Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 90 days prior to consent
- Untreated clinically significant coronary artery disease (CAD) requiring revascularization
- Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation
- Suboptimal ventricular anatomy or wall thickness as determined from screening echocardiography and/or CT scan
- 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)
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- Hemodynamic instability within 30 days prior to the implant defined as subject requiring inotropic support or mechanical hemodynamic support
- Any planned cardiac surgery or interventions within the next 180 days post-randomization (including therapeutic right heart procedures)
- Active bacterial endocarditis
- Severe RV dysfunction assessed by right heart catheterization (RHC) and/or TTE
- Fixed pulmonary hypertension with PA systolic pressure >70 mmHg not responsive to vasodilator therapy
- History of any stroke within the prior 90 days of consent or documented Modified Rankin Scale ≥ 2 disability from any prior stroke
- Valvular
- Mitral regurgitation grade 3+ (moderate-severe) or 4+ (severe)
- Untreated degenerative (primary) mitral valve disease (mild prolapse with no need for intervention is allowable)
- Prior mitral or aortic valve replacement
- Tricuspid regurgitation grade 4+ (severe)
- Moderate or severe aortic valve stenosis (AVA less than 1.5 cm2 or peak velocity AV Vmax >300 cm/sec)
- Aortic regurgitation grade 2+ (moderate), 3+ (moderate-severe), or 4+ (severe)
- Procedural
- 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)
- Renal insufficiency (i.e., eGFR of <25 ml/min/1.73 m2)
- Subjects in whom anticoagulation during the procedure is contraindicated
- Subjects in whom 90 days of antiplatelet therapy is contraindicated
- Known allergy to nitinol, polyester, or polyethylene
- 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
- Life expectancy <1 year due to non-cardiac conditions
- Currently participating in another interventional investigational study
- Subjects on high dose steroids or immunosuppressant therapy
- Female subjects who are pregnant, of child-bearing potential without a documented birth control method, or who are lactating
Trial locations and contacts
122 sites in 10 countries.
122 sites in 10 countries
United States96 sites
New Mexico Heart Institute
Albuquerque, New Mexico, 87102
University of Michigan
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30308
Northside Hospital
Atlanta, Georgia, 30342
JFK Medical Center
Atlantis, Florida, 33462
Ascension Texas Cardiovascular
Austin, Texas, 78705
Austin Heart
Austin, Texas, 78756
University of Maryland Medical Center
Baltimore, Maryland, 21201
Northern Light Eastern Maine Medical Center
Bangor, Maine, 04401
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, 70808
Grandview Medical Group Research, LLC
Birmingham, Alabama, 35243
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Deborah Heart & Lung
Browns Mills, New Jersey, 08015
University at Buffalo
Buffalo, New York, 14203
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425
Charleston Area Medical Center
Charleston, West Virginia, 25304
University of Virginia Health System
Charlottesville, Virginia, 22908
University of Chicago Medical Center
Chicago, Illinois, 60637
The Christ Hospital
Cincinnati, Ohio, 45219
Cleveland Clinic
Cleveland, Ohio, 44195
Prisma Health
Columbia, South Carolina, 29203
Ohio State University
Columbus, Ohio, 43210
Metropolitan Heart and Vascular Institute & Mercy Hosp
Coon Rapids, Minnesota, 55433
Baylor Scott & White Research Institute
Dallas, Texas, 75226
Geisinger Clinic
Danville, Pennsylvania, 17822
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
Spectrum Health
Grand Rapids, Michigan, 49503
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Hartford Health
Hartford, Connecticut, 06102
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
Cardiovascular Institute of the South
Houma, Louisiana, 70360
Houston Heart
Houston, Texas, 77004
Baylor College of Medicine St. Luke's Medical Center
Houston, Texas, 77020
UT Health
Houston, Texas, 77030
Jackson Heart Clinic
Jackson, Mississippi, 39216
University of Kansas Medical Center
Kansas City, Kansas, 66160
Tennova Healthcare-Turkey Creek Medical Center
Knoxville, Tennessee, 37934
University of California San Diego
La Jolla, California, 92037
Scripps Health
La Jolla, California, 92121
HCA Florida Largo Hospital
Largo, Florida, 33770
University of Kentucky
Lexington, Kentucky, 40536
University of Southern California
Los Angeles, California, 90033
Norton Heart Specialists
Louisville, Kentucky, 40216
Northwell Health
Manhasset, New York, 11030
University of Miami
Miami, Florida, 33136
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
University of Minnesota
Minneapolis, Minnesota, 55414
Ascension Saint Thomas
Nashville, Tennessee, 37221
Vanderbilt University Medical Center
Nashville, Tennessee, 87232
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
Yale University
New Haven, Connecticut, 06519
NYU Langone Health
New York, New York, 10016
Mount Sinai Hospital
New York, New York, 10029
CUMC/New York Presbyterian Hospital
New York, New York, 10032
Weill Cornell Medicine-New York Presbyterian Hospital
New York, New York, 10065
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, 73112
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120
University of California Irvine Medical Center
Orange, California, 92868
Ascension Sacred Heart
Pensacola, Florida, 32504
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Dignity Health St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
Phoenix Cardiovascular Research Group
Phoenix, Arizona, 85016
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
UPMC Heart and Vascular Institute
Pittsburgh, Pennsylvania, 15232
Baylor Scott & White
Plano, Texas, 75093
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Oregon Health & Science University
Portland, Oregon, 97239
Vassar Brothers Medical Center
Poughkeepsie, New York, 12601
Rhode Island Hospital
Providence, Rhode Island, 02904
NC Heart and Vascular Research, LLC
Raleigh, North Carolina, 27607
CJW Chippenham Medical Center
Richmond, Virginia, 23225
Bon Secours St Mary's Hospital
Richmond, Virginia, 23226
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014
St. Francis Hospital
Roslyn, New York, 11576
William Beaumont Hospital
Royal Oak, Michigan, 48073
Intermountain Medical Center
Salt Lake City, Utah, 84109
Methodist Healthcare System, San Antonio
San Antonio, Texas, 78229
Kaiser Permanente San Francisco
San Francisco, California, 94115
University of California, San Francisco
San Francisco, California, 94143
University of Washington
Seattle, Washington, 98195
Ascension Providence Hospital
Southfield, Michigan, 48075
Providence Sacred Heart Medical Center
Spokane, Washington, 99204
Washington University in St. Louis
St Louis, Missouri, 63110
University of South Florida
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10467
Tucson Medical Center
Tucson, Arizona, 85712
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104
Medstar Health Research Institute
Washington D.C., District of Columbia, 20010
Cardiovascular Research Institute of Kansas
Wichita, Kansas, 67226
Valley Health Winchester
Winchester, Virginia, 22601
University of Massachusetts
Worcester, Massachusetts, 01655
Germany5 sites
Immanuel Klinikum Bernau Herzzentrum Brandenburg Universitätsklinikum der Medizinischen Hochschule Brandenburg
Bernau, 16321
Universitätsklinikum Köln (AöR)
Cologne, 50937
CardioVasculäres Centrum
Frankfurt, 60389
Universitätsklinikum Halle (Saale)
Halle, 06120
Universitäres Herz- und Gefäßzentrum Hamburg
Hamburg, 20246
Italy4 sites
A O U Policlinico G. Rodolico - San Marco
Catania, Catania, 95123
IRCCS Istituto Clinico Humanitas
Milan, Lombardy, 20089
Centro Cardiologico Monzino S.p.a
Milan, 20138
AOU Città della salute e della Scienza - Ospedale Molinette
Torino, Torino, 10126
Serbia4 sites
Institute of Cardiovascular Diseases of Vojvodina
Belgrade, 11000
Institute of Cardiovascular Diseases
Belgrade, 11000
University Clinical Centre of Serbia
Belgrade, 11000
University Clinical Center Niš
Niš, 18108
France3 sites
Hôpital de la Timone
Marseille, 13005
CHU de Rennes - Hôpital Pontchaillou
Rennes, 35033
Clinique-Pasteur
Toulouse, 31300
Greece3 sites
Hygeia Hospital
Athens
Onassis Cardiac Surgery Center
Kallithea, 17674
Interbalkan Medical Hospital of Thessaloniki
Thessaloniki, 57001
Belgium2 sites
OLV Heart Centre
Aalst, 9300
AZ Sint-Jan-Oostende AV Campus Brugge
Bruges
Czechia2 sites
St. Anne's University Hospital
Brno, 60200
Na Homolce Hospital
Prague
Netherlands2 sites
St. Antonius Ziekenhuis
Nieuwegein
Erasmus Medical Center
Rotterdam
Belarus1 site
Republican Scientific and Practical Centre of Cardiology
Minsk, 220036
About this study
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
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).
Read the detailed description
The CORCINCH-HF Study is a prospective, randomized, open-label, multicenter, international, clinical safety and efficacy investigation of the AccuCinch Ventricular Restoration System.
Subjects will be randomized in a 1:1 ratio:
- Treatment group: AccuCinch Ventricular Restoration System plus guideline-directed medical therapy (GDMT) (n~200)
- Control group: Guideline-directed medical therapy (GDMT) (n~200)
- Being tested
- AccuCinch Ventricular Restoration System, Guideline-Directed Medical Therapy
- Keywords
- Heart Failure, Reduced Ejection Fraction, Cardiomyopathy
- Medical subject headings
- Cardiomyopathy, Dilated, Heart Failure, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccuCinch Ventricular Restoration SystemDevice
AccuCinch Ventricular Restoration System
Guideline-Directed Medical TherapyDrug
Guideline-Directed Medical Therapy
| Study group | Role | What they receive |
|---|---|---|
| Device group: AccuCinch Ventricular Restoration System | Experimental | Subjects in this arm will receive the AccuCinch Ventricular Restoration System Receives: Device: AccuCinch Ventricular Restoration System |
| Control group: Guideline-Directed Medical Therapy | Active comparator | Subjects in this arm will receive guideline-directed medical therapy (GDMT) Receives: Drug: Guideline-Directed Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from device- or femoral artery access-related major adverse events (MAE)
MAE defined as:
- All-cause death,
- Myocardial infarction,
- Stroke,
- Need for non-elective cardiovascular surgery,
- Worsening of heart-failure requiring mechanical circulatory support for more than 24 hours
- Acute kidney injury requiring renal replacement therapy
Measured: 180 days
Change from baseline in Kansas City Cardiomyopathy Questionnaire Quality of Life Questionnaire (KCCQ) Score
Higher scores in the KCCQ reflect better health status
Measured: 180 days
6-Minute Walk Test (6MWT) distance (m)
Change in 6MWT distance (m) from baseline
Measured: 180 days
Freedom from device- or femoral artery access-related major adverse events (MAE)
MAE defined as:
- All-cause death,
- Myocardial infarction,
- Stroke,
- Need for non-elective cardiovascular surgery,
- Worsening of heart-failure requiring mechanical circulatory support for more than 24 hours
- Acute kidney injury requiring renal replacement therapy
Measured: 365 days
A hierarchical composite endpoint of all-cause deaths, left ventricular assist device (LVAD) implants or heart transplants, heart failure hospitalizations, and changes from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS)
A hierarchical composite endpoint of number of all-cause deaths, number of left ventricular assist device (LVAD) implants or heart transplants, number of heart failure hospitalizations, and change from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS), evaluated using the Win Ratio method
Measured: 365 days
Secondary outcomes (16)
Number of all-cause deaths or all-cause hospitalizations
Measured: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Number of all-cause deaths
Measured: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Number of all-cause hospitalizations
Measured: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Incidence of all serious adverse events, including device- and procedure- related complications
Measured: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Changes from baseline in New York Heart Association (NYHA) functional class
Measured: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Changes from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS)
Higher scores in the KCCQ reflect better health status
Measured: 30 days, 90 days, 365 days, 545 days, 730 days
Changes from baseline in 6-Minute Walk Test (6MWT)
Measure in meters
Measured: 30 days, 90 days, 365 days, 545 days, 730 days
Changes in left ventricular ejection fraction (LVEF) from baseline and from post-procedure/pre-hospital discharge as assessed by echo
Measured: 30 days, 90 days, 365 days, 730 days
Changes in left ventricular ejection fraction (LVEF) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT
Measured: 180 days
Changes in left ventricular end-diastolic volume (LVEDV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo
Measured: 30 days, 90 days, 365 days, 730 days
Changes in left ventricular end-diastolic volume (LVEDV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT
Measured: 180 days
Changes in left ventricular end-systolic volume (LVESV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo
Measured: 30 days, 90 days, 365 days, 730 days
Changes in left ventricular end-systolic volume (LVESV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT
Measured: 180 days
Rate and number of cardiovascular death events
Measured: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Rate and number of heart failure death events
Measured: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Rate and number of heart failure-related hospitalizations
Measured: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start21 Dec 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion21 Dec 2030 (estimated)
Why it stopped: Recruitment on hold pending modifications to the clinical investigation plan
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Reduced Ejection Fraction (HFrEF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ancora Heart, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin B Leon, MD, Study chair, Columbia UniversityUlrich P Jorde, MD, Principal investigator, Montefiore Medical Center/Albert Einstein College of MedicineShmuel Chen, MD, Principal investigator, New York Presbyterian/Weill Cornell Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331769
- Sponsor's protocol ID
- 5019
- Status last verified
- Dec 2025
- First submitted
- 30 Mar 2020
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Hamid N, Jorde UP, Reisman M, Latib A, Lim DS, Joseph SM, Kurlianskaya A, Polonetsky O, Neuzil P, Reddy V, Foerst J, Gada H, Grubb KJ, Silva G, Kereiakes D, Shreenivas S, Pinney S, Davidavicius G, Sorajja P, Boehmer JP, Kleber FX, Perier P, VAN Mieghem NM, Dumonteil N, Leon MB, Burkhoff D. Transcatheter Left Ventricular Restoration in Patients With Heart Failure. J Card Fail. 2023 Jul;29(7):1046-1055. doi: 10.1016/j.cardfail.2023.03.003. Epub 2023 Mar 22.
PubMed 36958391
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04331769
- Acronym / sponsor ID
- 5019
- Keywords
- Heart Failure, Reduced Ejection Fraction, Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Recruitment on hold pending modifications to the clinical investigation plan
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ancora Heart, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 21 Dec 2030 (estimated)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The CORCINCH-HF Study is a prospective, randomized, open-label, multicenter, international, clinical safety and efficacy investigation of the AccuCinch Ventricular Restoration System.
Subjects will be randomized in a 1:1 ratio:
- Treatment group: AccuCinch Ventricular Restoration System plus guideline-directed medical therapy (GDMT) (n~200)
- Control group: Guideline-directed medical therapy (GDMT) (n~200)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device group: AccuCinch Ventricular Restoration System | Experimental | Device: AccuCinch Ventricular Restoration SystemSubjects in this arm will receive the AccuCinch Ventricular Restoration System |
| Control group: Guideline-Directed Medical Therapy | Active comparator | Drug: Guideline-Directed Medical TherapySubjects in this arm will receive guideline-directed medical therapy (GDMT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age 18-years or older
- Ejection Fraction: ≥20% and ≤40% measured by transthoracic echocardiography (TTE) and assessed by an echocardiography (echo) core lab
- LV end-diastolic diameter ≥55 mm measured by TTE and assessed by an echo core lab
- Symptom Status:
- Able to complete six-minute walk test with distance between 100 m and 450 m.
Key exclusion criteria (31 listed)
- Cardiovascular
- Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 90 days prior to consent
- Untreated clinically significant coronary artery disease (CAD) requiring revascularization
- Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation
- Suboptimal ventricular anatomy or wall thickness as determined from screening echocardiography and/or CT scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AccuCinch Ventricular Restoration SystemAccuCinch Ventricular Restoration System | Device | Device group: AccuCinch Ventricular Restoration System |
| Guideline-Directed Medical TherapyGuideline-Directed Medical Therapy | Drug | Control group: Guideline-Directed Medical Therapy |
Primary outcome
Freedom from device- or femoral artery access-related major adverse events (MAE)
Time frame: 180 days
MAE defined as: 1. All-cause death, 2. Myocardial infarction, 3. Stroke, 4. Need for non-elective cardiovascular surgery, 5. Worsening of heart-failure requiring mechanical circulatory support for more than 24 hours 6. Acute kidney injury requiring renal replacement therapy
Change from baseline in Kansas City Cardiomyopathy Questionnaire Quality of Life Questionnaire (KCCQ) Score
Time frame: 180 days
Higher scores in the KCCQ reflect better health status
6-Minute Walk Test (6MWT) distance (m)
Time frame: 180 days
Change in 6MWT distance (m) from baseline
Freedom from device- or femoral artery access-related major adverse events (MAE)
Time frame: 365 days
MAE defined as: 1. All-cause death, 2. Myocardial infarction, 3. Stroke, 4. Need for non-elective cardiovascular surgery, 5. Worsening of heart-failure requiring mechanical circulatory support for more than 24 hours 6. Acute kidney injury requiring renal replacement therapy
A hierarchical composite endpoint of all-cause deaths, left ventricular assist device (LVAD) implants or heart transplants, heart failure hospitalizations, and changes from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS)
Time frame: 365 days
A hierarchical composite endpoint of number of all-cause deaths, number of left ventricular assist device (LVAD) implants or heart transplants, number of heart failure hospitalizations, and change from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS), evaluated using the Win Ratio method
16 secondary outcomes
Number of all-cause deaths or all-cause hospitalizations
Time frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Number of all-cause deaths
Time frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Number of all-cause hospitalizations
Time frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Incidence of all serious adverse events, including device- and procedure- related complications
Time frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Changes from baseline in New York Heart Association (NYHA) functional class
Time frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Changes from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS)
Time frame: 30 days, 90 days, 365 days, 545 days, 730 days
Changes from baseline in 6-Minute Walk Test (6MWT)
Time frame: 30 days, 90 days, 365 days, 545 days, 730 days
Changes in left ventricular ejection fraction (LVEF) from baseline and from post-procedure/pre-hospital discharge as assessed by echo
Time frame: 30 days, 90 days, 365 days, 730 days
Changes in left ventricular ejection fraction (LVEF) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT
Time frame: 180 days
Changes in left ventricular end-diastolic volume (LVEDV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo
Time frame: 30 days, 90 days, 365 days, 730 days
Changes in left ventricular end-diastolic volume (LVEDV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT
Time frame: 180 days
Changes in left ventricular end-systolic volume (LVESV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo
Time frame: 30 days, 90 days, 365 days, 730 days
Changes in left ventricular end-systolic volume (LVESV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT
Time frame: 180 days
Rate and number of cardiovascular death events
Time frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Rate and number of heart failure death events
Time frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Rate and number of heart failure-related hospitalizations
Time frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Derived from this study: PubMed 36958391Hamid N, Jorde UP, Reisman M, Latib A, Lim DS, Joseph SM, Kurlianskaya A, Polonetsky O, Neuzil P, Reddy V, Foerst J, Gada H, Grubb KJ, Silva G, Kereiakes D, Shreenivas S, Pinney S, Davidavicius G, Sorajja P, Boehmer JP, Kleber FX, Perier P, VAN Mieghem NM, Dumonteil N, Leon MB, Burkhoff D. Transcatheter Left Ventricular Restoration in Patients With Heart Failure. J Card Fail. 2023 Jul;29(7):1046-1055. doi: 10.1016/j.cardfail.2023.03.003. Epub 2023 Mar 22.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin B Leon, MD study chair
Columbia University
Ulrich P Jorde, MD principal investigator
Montefiore Medical Center/Albert Einstein College of Medicine
Shmuel Chen, MD principal investigator
New York Presbyterian/Weill Cornell Medicine
122 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AccuCinch Ventricular Restoration System and Guideline-Directed Medical Therapy in people with Heart Failure With Reduced Ejection Fraction (HFrEF) and Dilated Cardiomyopathy, run by Ancora Heart, Inc. at 122 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 122 sites in United States, Germany, Italy, Serbia, France and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from device- or femoral artery access-related major adverse events (MAE) (time frame: 180 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04331769, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.