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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

Megadott ok: Recruitment on hold pending modifications to the clinical investigation plan

A legfontosabb adatok

Hol
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 és Worcester (Egyesült Államok)Mind a 96 helyszín megnézése

Helyszínek itt: Egyesült Államok

  • New Mexico Heart InstituteAlbuquerque, Egyesült ÁllamokNo longer taking part
  • University of MichiganAnn Arbor, Egyesült ÁllamokNo longer taking part
  • Emory UniversityAtlanta, Egyesült ÁllamokNo longer taking part
  • Northside HospitalAtlanta, Egyesült ÁllamokNo longer taking part
  • JFK Medical CenterAtlantis, Egyesült ÁllamokNo longer taking part
  • Ascension Texas CardiovascularAustin, Egyesült ÁllamokNo longer taking part
  • Austin HeartAustin, Egyesült ÁllamokNo longer taking part
  • University of Maryland Medical CenterBaltimore, Egyesült ÁllamokNo longer taking part
  • Northern Light Eastern Maine Medical CenterBangor, Egyesült ÁllamokNo longer taking part
  • Our Lady of the Lake Regional Medical CenterBaton Rouge, Egyesült ÁllamokNo longer taking part
  • Grandview Medical Group Research, LLCBirmingham, Egyesült ÁllamokNo longer taking part
  • Beth Israel Deaconess Medical CenterBoston, Egyesült ÁllamokNo longer taking part
  • Massachusetts General HospitalBoston, Egyesült ÁllamokNo longer taking part
  • Deborah Heart & LungBrowns Mills, Egyesült ÁllamokNo longer taking part
  • University at BuffaloBuffalo, Egyesült ÁllamokNo longer taking part
  • University of North Carolina at Chapel HillChapel Hill, Egyesült ÁllamokNo longer taking part
  • Charleston Area Medical CenterCharleston, Egyesült ÁllamokNo longer taking part
  • Medical University of South CarolinaCharleston, Egyesült ÁllamokNo longer taking part
  • University of Virginia Health SystemCharlottesville, Egyesült ÁllamokNo longer taking part
  • University of Chicago Medical CenterChicago, Egyesült ÁllamokNo longer taking part
  • The Christ HospitalCincinnati, Egyesült ÁllamokNo longer taking part
  • Cleveland ClinicCleveland, Egyesült ÁllamokNo longer taking part
  • Prisma HealthColumbia, Egyesült ÁllamokNo longer taking part
  • Ohio State UniversityColumbus, Egyesült ÁllamokNo longer taking part
  • Metropolitan Heart and Vascular Institute & Mercy HospCoon Rapids, Egyesült ÁllamokNo longer taking part
  • Baylor Scott & White Research InstituteDallas, Egyesült ÁllamokNo longer taking part
  • Geisinger ClinicDanville, Egyesült ÁllamokNo longer taking part
  • Advocate Good Samaritan HospitalDowners Grove, Egyesült ÁllamokNo longer taking part
  • Spectrum HealthGrand Rapids, Egyesült ÁllamokNo longer taking part
  • Hackensack University Medical CenterHackensack, Egyesült ÁllamokNo longer taking part
  • Hartford HealthHartford, Egyesült ÁllamokNo longer taking part
  • Penn State Hershey Medical CenterHershey, Egyesült ÁllamokNo longer taking part
  • Cardiovascular Institute of the SouthHouma, Egyesült ÁllamokNo longer taking part
  • Baylor College of Medicine St. Luke's Medical CenterHouston, Egyesült ÁllamokNo longer taking part
  • Houston HeartHouston, Egyesült ÁllamokNo longer taking part
  • UT HealthHouston, Egyesült ÁllamokNo longer taking part
  • Jackson Heart ClinicJackson, Egyesült ÁllamokNo longer taking part
  • University of Kansas Medical CenterKansas City, Egyesült ÁllamokNo longer taking part
  • Tennova Healthcare-Turkey Creek Medical CenterKnoxville, Egyesült ÁllamokNo longer taking part
  • Scripps HealthLa Jolla, Egyesült ÁllamokNo longer taking part
  • University of California San DiegoLa Jolla, Egyesült ÁllamokNo longer taking part
  • HCA Florida Largo HospitalLargo, Egyesült ÁllamokNo longer taking part
  • University of KentuckyLexington, Egyesült ÁllamokNo longer taking part
  • University of Southern CaliforniaLos Angeles, Egyesült ÁllamokNo longer taking part
  • Norton Heart SpecialistsLouisville, Egyesült ÁllamokNo longer taking part
  • Northwell HealthManhasset, Egyesült ÁllamokNo longer taking part
  • University of MiamiMiami, Egyesült ÁllamokNo longer taking part
  • Aurora St. Luke's Medical CenterMilwaukee, Egyesült ÁllamokNo longer taking part
  • Medical College of WisconsinMilwaukee, Egyesült ÁllamokNo longer taking part
  • Minneapolis Heart Institute FoundationMinneapolis, Egyesült ÁllamokNo longer taking part
  • University of MinnesotaMinneapolis, Egyesült ÁllamokNo longer taking part
  • Ascension Saint ThomasNashville, Egyesült ÁllamokNo longer taking part
  • Vanderbilt University Medical CenterNashville, Egyesült ÁllamokNo longer taking part
  • Rutgers, Robert Wood Johnson Medical SchoolNew Brunswick, Egyesült ÁllamokNo longer taking part
  • Yale UniversityNew Haven, Egyesült ÁllamokNo longer taking part
  • CUMC/New York Presbyterian HospitalNew York, Egyesült ÁllamokNo longer taking part
  • Mount Sinai HospitalNew York, Egyesült ÁllamokNo longer taking part
  • NYU Langone HealthNew York, Egyesült ÁllamokNo longer taking part
  • Weill Cornell Medicine-New York Presbyterian HospitalNew York, Egyesült ÁllamokNo longer taking part
  • Sentara Norfolk General HospitalNorfolk, Egyesült ÁllamokNo longer taking part
  • Integris Baptist Medical CenterOklahoma City, Egyesült ÁllamokNo longer taking part
  • Oklahoma Heart HospitalOklahoma City, Egyesült ÁllamokNo longer taking part
  • University of California Irvine Medical CenterOrange, Egyesült ÁllamokNo longer taking part
  • Ascension Sacred HeartPensacola, Egyesült ÁllamokNo longer taking part
  • Thomas Jefferson UniversityPhiladelphia, Egyesült ÁllamokNo longer taking part
  • Dignity Health St Joseph's Hospital and Medical CenterPhoenix, Egyesült ÁllamokNo longer taking part
  • Phoenix Cardiovascular Research GroupPhoenix, Egyesült ÁllamokNo longer taking part
  • Allegheny General HospitalPittsburgh, Egyesült ÁllamokNo longer taking part
  • UPMC Heart and Vascular InstitutePittsburgh, Egyesült ÁllamokNo longer taking part
  • Baylor Scott & WhitePlano, Egyesült ÁllamokNo longer taking part
  • Oregon Health Science UniversityPortland, Egyesült ÁllamokNo longer taking part
  • Providence St. Vincent Medical CenterPortland, Egyesült ÁllamokNo longer taking part
  • Vassar Brothers Medical CenterPoughkeepsie, Egyesült ÁllamokNo longer taking part
  • Rhode Island HospitalProvidence, Egyesült ÁllamokNo longer taking part
  • NC Heart and Vascular Research, LLCRaleigh, Egyesült ÁllamokNo longer taking part
  • Bon Secours St. Mary's HospitalRichmond, Egyesült ÁllamokNo longer taking part
  • CJW Chippenham Medical CenterRichmond, Egyesült ÁllamokNo longer taking part
  • Carilion Roanoke Memorial HospitalRoanoke, Egyesült ÁllamokNo longer taking part
  • St. Francis HospitalRoslyn, Egyesült ÁllamokNo longer taking part
  • William Beaumont HospitalRoyal Oak, Egyesült ÁllamokNo longer taking part
  • Intermountain Medical CenterSalt Lake City, Egyesült ÁllamokNo longer taking part
  • Methodist Healthcare System, San AntonioSan Antonio, Egyesült ÁllamokNo longer taking part
  • Kaiser Permanente-San FranciscoSan Francisco, Egyesült ÁllamokNo longer taking part
  • University of California San FranciscoSan Francisco, Egyesült ÁllamokNo longer taking part
  • University of WashingtonSeattle, Egyesült ÁllamokNo longer taking part
  • Ascension Providence HospitalSouthfield, Egyesült ÁllamokNo longer taking part
  • Providence Sacred Heart Medical CenterSpokane, Egyesült ÁllamokNo longer taking part
  • Washington University in St. LouisSt Louis, Egyesült ÁllamokNo longer taking part
  • University of South FloridaTampa, Egyesült ÁllamokNo longer taking part
  • Montefiore Medical CenterThe Bronx, Egyesült ÁllamokNo longer taking part
  • Tucson Medical CenterTucson, Egyesült ÁllamokNo longer taking part
  • Oklahoma Heart InstituteTulsa, Egyesült ÁllamokNo longer taking part
  • Medstar Health Research InstituteWashington D.C., Egyesült ÁllamokNo longer taking part
  • Cardiovascular Research Institute of KansasWichita, Egyesült ÁllamokNo longer taking part
  • Valley Health WinchesterWinchester, Egyesült ÁllamokNo longer taking part
  • University of MassachusettsWorcester, Egyesült ÁllamokNo longer taking part

A vizsgálat adatai

Ki végzi
Ancora Heart, Inc.
Azonosító
NCT04331769
A regiszteradat frissítve
2026. június 3.
Eredeti leírás
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).A teljes eredeti leírásKevesebb

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).

Bevonási feltételek: 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.

Kizáró feltételek: 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.

ClinicalTrials.gov NCT04331769