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
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
1 other identifier
interventional
400
9 countries
131
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2020
Longer than P75 for not_applicable
131 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2020
CompletedFirst Posted
Study publicly available on registry
April 2, 2020
CompletedStudy Start
First participant enrolled
December 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 21, 2030
December 11, 2025
December 1, 2025
6 years
March 30, 2020
December 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Freedom from device- or femoral artery access-related major adverse events (MAE)
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
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
180 days
6-Minute Walk Test (6MWT) distance (m)
Change in 6MWT distance (m) from baseline
180 days
Freedom from device- or femoral artery access-related major adverse events (MAE)
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
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
365 days
Secondary Outcomes (16)
Number of all-cause deaths or all-cause hospitalizations
30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Number of all-cause deaths
30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Number of all-cause hospitalizations
30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Incidence of all serious adverse events, including device- and procedure- related complications
30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Changes from baseline in New York Heart Association (NYHA) functional class
30 days, 90 days, 180 days, 365 days, 545 days, 730 days
- +11 more secondary outcomes
Other Outcomes (9)
Changes from baseline in mitral effective regurgitant orifice area (EROA)
30 days, 90 days, 180 days, 365 days, 730 days
Changes from baseline in left atrial strain measured by Echo
30 days, 90 days, 180 days, 365 days, 730 days
Changes from baseline in left ventricular global longitudinal strain measured by Echo
30 days, 90 days, 180 days, 365 days, 730 days
- +6 more other outcomes
Study Arms (2)
Device group: AccuCinch Ventricular Restoration System
EXPERIMENTALSubjects in this arm will receive the AccuCinch Ventricular Restoration System
Control group: Guideline-Directed Medical Therapy
ACTIVE COMPARATORSubjects in this arm will receive guideline-directed medical therapy (GDMT)
Interventions
AccuCinch Ventricular Restoration System
Guideline-Directed Medical Therapy
Eligibility Criteria
You may qualify if:
- 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
- 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
- +4 more criteria
You may not qualify if:
- 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)
- 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)
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (132)
Grandview Medical Group Research, LLC
Birmingham, Alabama, 35243, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Dignity Health St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Phoenix Cardiovascular Research Group
Phoenix, Arizona, 85016, United States
Tucson Medical Center
Tucson, Arizona, 85712, United States
Baptist Health Heart Failure & Transplant Institute
Little Rock, Arkansas, 72205, United States
University of California San Diego
La Jolla, California, 92037, United States
Scripps Health
La Jolla, California, 92121, United States
University of Southern California
Los Angeles, California, 90033, United States
Kaiser Permanente San Francisco
San Francisco, California, 94115, United States
University of California, San Francisco
San Francisco, California, 94143, United States
University of Colorado
Aurora, Colorado, 80045, United States
Hartford Health
Hartford, Connecticut, 06102, United States
Yale University
New Haven, Connecticut, 06519, United States
Medstar Health Research Institute
Washington D.C., District of Columbia, 20010, United States
JFK Medical Center
Atlantis, Florida, 33462, United States
HCA Florida Largo Hospital
Largo, Florida, 33770, United States
University of Miami
Miami, Florida, 33136, United States
Ascension Sacred Heart
Pensacola, Florida, 32504, United States
University of South Florida
Tampa, Florida, 33606, United States
Emory University
Atlanta, Georgia, 30308, United States
Piedmont Heart Institute
Atlanta, Georgia, 30309, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Cardiovascular Research Institute of Kansas
Wichita, Kansas, 67226, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Norton Heart Specialists
Louisville, Kentucky, 40216, United States
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, 70808, United States
Cardiovascular Institute of the South
Houma, Louisiana, 70360, United States
Northern Light Eastern Maine Medical Center
Bangor, Maine, 04401, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Massachusetts
Worcester, Massachusetts, 01655, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Spectrum Health
Grand Rapids, Michigan, 49503, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Ascension Providence Hospital
Southfield, Michigan, 48075, United States
Metropolitan Heart and Vascular Institute & Mercy Hosp
Coon Rapids, Minnesota, 55433, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
University of Minnesota
Minneapolis, Minnesota, 55414, United States
Jackson Heart Clinic
Jackson, Mississippi, 39216, United States
Washington University in St. Louis
St Louis, Missouri, 63110, United States
Deborah Heart & Lung
Browns Mills, New Jersey, 08015, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903, United States
New Mexico Heart Institute
Albuquerque, New Mexico, 87102, United States
University at Buffalo
Buffalo, New York, 14203, United States
Northwell Health
Manhasset, New York, 11030, United States
NYU Langone Health
New York, New York, 10016, United States
Mount Sinai Hospital
New York, New York, 10029, United States
CUMC/New York Presbyterian Hospital
New York, New York, 10032, United States
Weill Cornell Medicine-New York Presbyterian Hospital
New York, New York, 10065, United States
Vassar Brothers Medical Center
Poughkeepsie, New York, 12601, United States
St. Francis Hospital
Roslyn, New York, 11576, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
NC Heart and Vascular Research, LLC
Raleigh, North Carolina, 27607, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
UH Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, 73112, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Geisinger Clinic
Danville, Pennsylvania, 17822, United States
Pinnacle Health Cardiovascular Institute
Harrisburg, Pennsylvania, 17101, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
UPMC Heart and Vascular Institute
Pittsburgh, Pennsylvania, 15232, United States
Rhode Island Hospital
Providence, Rhode Island, 02904, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Prisma Health
Columbia, South Carolina, 29203, United States
Tennova Healthcare-Turkey Creek Medical Center
Knoxville, Tennessee, 37934, United States
Ascension Saint Thomas
Nashville, Tennessee, 37221, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 87232, United States
Ascension Texas Cardiovascular
Austin, Texas, 78705, United States
Austin Heart
Austin, Texas, 78756, United States
Baylor Scott & White Research Institute
Dallas, Texas, 75226, United States
Houston Heart
Houston, Texas, 77004, United States
Baylor College of Medicine St. Luke's Medical Center
Houston, Texas, 77020, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
UT Health
Houston, Texas, 77030, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430, United States
Baylor Scott & White
Plano, Texas, 75093, United States
Methodist Healthcare System, San Antonio
San Antonio, Texas, 78229, United States
Intermountain Medical Center
Salt Lake City, Utah, 84109, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
CJW Chippenham Medical Center
Richmond, Virginia, 23225, United States
Bon Secours St Mary's Hospital
Richmond, Virginia, 23226, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014, United States
Valley Health Winchester
Winchester, Virginia, 22601, United States
University of Washington
Seattle, Washington, 98195, United States
Providence Sacred Heart Medical Center
Spokane, Washington, 99204, United States
Charleston Area Medical Center
Charleston, West Virginia, 25304, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Republican Scientific and Practical Centre of Cardiology
Minsk, 220036, Belarus
OLV Heart Centre
Aalst, 9300, Belgium
AZ Sint-Jan-Oostende AV Campus Brugge
Bruges, Belgium
St. Anne's University Hospital
Brno, 60200, Czechia
Na Homolce Hospital
Prague, Czechia
Hôpital de la Timone
Marseille, 13005, France
CHU de Rennes - Hôpital Pontchaillou
Rennes, 35033, France
Clinique-Pasteur
Toulouse, 31300, France
Immanuel Klinikum Bernau Herzzentrum Brandenburg Universitätsklinikum der Medizinischen Hochschule Brandenburg
Bernau, 16321, Germany
Universitätsklinikum Köln (AöR)
Cologne, 50937, Germany
CardioVasculäres Centrum
Frankfurt, 60389, Germany
Universitätsklinikum Halle (Saale)
Halle, 06120, Germany
Universitäres Herz- und Gefäßzentrum Hamburg
Hamburg, 20246, Germany
Hygeia Hospital
Athens, Greece
Onassis Cardiac Surgery Center
Kallithea, 17674, Greece
Interbalkan Medical Hospital of Thessaloniki
Thessaloniki, 57001, Greece
A O U Policlinico G. Rodolico - San Marco
Catania, Catania, 95123, Italy
IRCCS Istituto Clinico Humanitas
Milan, Lombardy, 20089, Italy
AOU Città della salute e della Scienza - Ospedale Molinette
Torino, Torino, 10126, Italy
Centro Cardiologico Monzino S.p.a
Milan, 20138, Italy
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Institute of Cardiovascular Diseases of Vojvodina
Belgrade, 11000, Serbia
Institute of Cardiovascular Diseases
Belgrade, 11000, Serbia
University Clinical Centre of Serbia
Belgrade, 11000, Serbia
University Clinical Center Niš
Niš, 18108, Serbia
Related Publications (1)
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.
PMID: 36958391DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Martin B Leon, MD
Columbia University
- PRINCIPAL INVESTIGATOR
Ulrich P Jorde, MD
Montefiore Medical Center/Albert Einstein College of Medicine
- PRINCIPAL INVESTIGATOR
Shmuel Chen, MD
New York Presbyterian/Weill Cornell Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2020
First Posted
April 2, 2020
Study Start
December 21, 2020
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 21, 2030
Last Updated
December 11, 2025
Record last verified: 2025-12