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
Reason given: Recruitment on hold pending modifications to the clinical investigation plan
Key facts
- Where
- Albuquerque, Ann Arbor, Atlanta, Atlantis, Austin, Baltimore, Bangor, Baton Rouge, Birmingham, Boston, Browns Mills, Buffalo, Chapel Hill, Charleston, Charlottesville, Chicago, Cincinnati, Cleveland, Columbia, Columbus, Coon Rapids, Dallas, Danville, Downers Grove, Grand Rapids, Hackensack, Hartford, Hershey, Houma, Houston, Jackson, Kansas City, Knoxville, La Jolla, Largo, Lexington, Los Angeles, Louisville, Manhasset, Miami, Milwaukee, Minneapolis, Nashville, New Brunswick, New Haven, New York, Norfolk, Oklahoma City, Orange, Pensacola, Philadelphia, Phoenix, Pittsburgh, Plano, Portland, Poughkeepsie, Providence, Raleigh, Richmond, Roanoke, Roslyn, Royal Oak, Salt Lake City, San Antonio, San Francisco, Seattle, Southfield, Spokane, St Louis, Tampa, The Bronx, Tucson, Tulsa, Washington D.C., Wichita, Winchester, and Worcester, United StatesSee the 96 sites
Where in United States
- New Mexico Heart InstituteAlbuquerque, United StatesNo longer taking part
- University of MichiganAnn Arbor, United StatesNo longer taking part
- Emory UniversityAtlanta, United StatesNo longer taking part
- Northside HospitalAtlanta, United StatesNo longer taking part
- JFK Medical CenterAtlantis, United StatesNo longer taking part
- Ascension Texas CardiovascularAustin, United StatesNo longer taking part
- Austin HeartAustin, United StatesNo longer taking part
- University of Maryland Medical CenterBaltimore, United StatesNo longer taking part
- Northern Light Eastern Maine Medical CenterBangor, United StatesNo longer taking part
- Our Lady of the Lake Regional Medical CenterBaton Rouge, United StatesNo longer taking part
- Grandview Medical Group Research, LLCBirmingham, United StatesNo longer taking part
- Beth Israel Deaconess Medical CenterBoston, United StatesNo longer taking part
- Massachusetts General HospitalBoston, United StatesNo longer taking part
- Deborah Heart & LungBrowns Mills, United StatesNo longer taking part
- University at BuffaloBuffalo, United StatesNo longer taking part
- University of North Carolina at Chapel HillChapel Hill, United StatesNo longer taking part
- Charleston Area Medical CenterCharleston, United StatesNo longer taking part
- Medical University of South CarolinaCharleston, United StatesNo longer taking part
- University of Virginia Health SystemCharlottesville, United StatesNo longer taking part
- University of Chicago Medical CenterChicago, United StatesNo longer taking part
- The Christ HospitalCincinnati, United StatesNo longer taking part
- Cleveland ClinicCleveland, United StatesNo longer taking part
- Prisma HealthColumbia, United StatesNo longer taking part
- Ohio State UniversityColumbus, United StatesNo longer taking part
- Metropolitan Heart and Vascular Institute & Mercy HospCoon Rapids, United StatesNo longer taking part
- Baylor Scott & White Research InstituteDallas, United StatesNo longer taking part
- Geisinger ClinicDanville, United StatesNo longer taking part
- Advocate Good Samaritan HospitalDowners Grove, United StatesNo longer taking part
- Spectrum HealthGrand Rapids, United StatesNo longer taking part
- Hackensack University Medical CenterHackensack, United StatesNo longer taking part
- Hartford HealthHartford, United StatesNo longer taking part
- Penn State Hershey Medical CenterHershey, United StatesNo longer taking part
- Cardiovascular Institute of the SouthHouma, United StatesNo longer taking part
- Baylor College of Medicine St. Luke's Medical CenterHouston, United StatesNo longer taking part
- Houston HeartHouston, United StatesNo longer taking part
- UT HealthHouston, United StatesNo longer taking part
- Jackson Heart ClinicJackson, United StatesNo longer taking part
- University of Kansas Medical CenterKansas City, United StatesNo longer taking part
- Tennova Healthcare-Turkey Creek Medical CenterKnoxville, United StatesNo longer taking part
- Scripps HealthLa Jolla, United StatesNo longer taking part
- University of California San DiegoLa Jolla, United StatesNo longer taking part
- HCA Florida Largo HospitalLargo, United StatesNo longer taking part
- University of KentuckyLexington, United StatesNo longer taking part
- University of Southern CaliforniaLos Angeles, United StatesNo longer taking part
- Norton Heart SpecialistsLouisville, United StatesNo longer taking part
- Northwell HealthManhasset, United StatesNo longer taking part
- University of MiamiMiami, United StatesNo longer taking part
- Aurora St. Luke's Medical CenterMilwaukee, United StatesNo longer taking part
- Medical College of WisconsinMilwaukee, United StatesNo longer taking part
- Minneapolis Heart Institute FoundationMinneapolis, United StatesNo longer taking part
- University of MinnesotaMinneapolis, United StatesNo longer taking part
- Ascension Saint ThomasNashville, United StatesNo longer taking part
- Vanderbilt University Medical CenterNashville, United StatesNo longer taking part
- Rutgers, Robert Wood Johnson Medical SchoolNew Brunswick, United StatesNo longer taking part
- Yale UniversityNew Haven, United StatesNo longer taking part
- CUMC/New York Presbyterian HospitalNew York, United StatesNo longer taking part
- Mount Sinai HospitalNew York, United StatesNo longer taking part
- NYU Langone HealthNew York, United StatesNo longer taking part
- Weill Cornell Medicine-New York Presbyterian HospitalNew York, United StatesNo longer taking part
- Sentara Norfolk General HospitalNorfolk, United StatesNo longer taking part
- Integris Baptist Medical CenterOklahoma City, United StatesNo longer taking part
- Oklahoma Heart HospitalOklahoma City, United StatesNo longer taking part
- University of California Irvine Medical CenterOrange, United StatesNo longer taking part
- Ascension Sacred HeartPensacola, United StatesNo longer taking part
- Thomas Jefferson UniversityPhiladelphia, United StatesNo longer taking part
- Dignity Health St Joseph's Hospital and Medical CenterPhoenix, United StatesNo longer taking part
- Phoenix Cardiovascular Research GroupPhoenix, United StatesNo longer taking part
- Allegheny General HospitalPittsburgh, United StatesNo longer taking part
- UPMC Heart and Vascular InstitutePittsburgh, United StatesNo longer taking part
- Baylor Scott & WhitePlano, United StatesNo longer taking part
- Oregon Health Science UniversityPortland, United StatesNo longer taking part
- Providence St. Vincent Medical CenterPortland, United StatesNo longer taking part
- Vassar Brothers Medical CenterPoughkeepsie, United StatesNo longer taking part
- Rhode Island HospitalProvidence, United StatesNo longer taking part
- NC Heart and Vascular Research, LLCRaleigh, United StatesNo longer taking part
- Bon Secours St. Mary's HospitalRichmond, United StatesNo longer taking part
- CJW Chippenham Medical CenterRichmond, United StatesNo longer taking part
- Carilion Roanoke Memorial HospitalRoanoke, United StatesNo longer taking part
- St. Francis HospitalRoslyn, United StatesNo longer taking part
- William Beaumont HospitalRoyal Oak, United StatesNo longer taking part
- Intermountain Medical CenterSalt Lake City, United StatesNo longer taking part
- Methodist Healthcare System, San AntonioSan Antonio, United StatesNo longer taking part
- Kaiser Permanente-San FranciscoSan Francisco, United StatesNo longer taking part
- University of California San FranciscoSan Francisco, United StatesNo longer taking part
- University of WashingtonSeattle, United StatesNo longer taking part
- Ascension Providence HospitalSouthfield, United StatesNo longer taking part
- Providence Sacred Heart Medical CenterSpokane, United StatesNo longer taking part
- Washington University in St. LouisSt Louis, United StatesNo longer taking part
- University of South FloridaTampa, United StatesNo longer taking part
- Montefiore Medical CenterThe Bronx, United StatesNo longer taking part
- Tucson Medical CenterTucson, United StatesNo longer taking part
- Oklahoma Heart InstituteTulsa, United StatesNo longer taking part
- Medstar Health Research InstituteWashington D.C., United StatesNo longer taking part
- Cardiovascular Research Institute of KansasWichita, United StatesNo longer taking part
- Valley Health WinchesterWinchester, United StatesNo longer taking part
- University of MassachusettsWorcester, United StatesNo longer taking part
Trial details
- Who runs it
- Ancora Heart, Inc.
- Trial code
- NCT04331769
- Record updated
- 3 June 2026
- Original description
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 full original descriptionShow less
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).
Inclusion: 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; 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.
Exclusion: Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 90 days prior to consent; Hemodynamic instability within 30 days prior to the implant defined as subject requiring inotropic support or mechanical hemodynamic support; History of any stroke within the prior 90 days of consent or documented Modified Rankin Scale ≥ 2 disability from any prior stroke; Valvular; Prior mitral or aortic valve replacement; 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); Subjects in whom 90 days of antiplatelet therapy is contraindicated; 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; Subjects on high dose steroids or immunosuppressant therapy; Untreated clinically significant coronary artery disease (CAD) requiring revascularization; 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); Any planned cardiac surgery or interventions within the next 180 days post-randomization (including therapeutic right heart procedures); 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; Untreated degenerative (primary) mitral valve disease (mild prolapse with no need for intervention is allowable); Known allergy to nitinol, polyester, or polyethylene; Life expectancy <1 year due to non-cardiac conditions; Renal insufficiency (i.e., eGFR of <25 ml/min/1.73 m2); Cardiovascular; 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; Active bacterial endocarditis; Mitral regurgitation grade 3+ (moderate-severe) or 4+ (severe); 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; Subjects in whom anticoagulation during the procedure is contraindicated; Currently participating in another interventional investigational study; Female subjects who are pregnant, of child-bearing potential without a documented birth control method, or who are lactating.