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
Heart Failure With Reduced Ejection Fraction (HFrEF), Dilated Cardiomyopathy
About this trial
This is an interventional treatment trial for Heart Failure With Reduced Ejection Fraction (HFrEF) focused on measuring Heart Failure, Reduced Ejection Fraction, Cardiomyopathy
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
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)
- 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
Sites / Locations
- Grandview Medical Group Research, LLCRecruiting
- University of Alabama at Birmingham
- Phoenix Cardiovascular Research GroupRecruiting
- Tucson Medical CenterRecruiting
- Baptist Health Heart Failure & Transplant Institute
- University of California San DiegoRecruiting
- Scripps HealthRecruiting
- University of Southern CaliforniaRecruiting
- Kaiser Permanente San FranciscoRecruiting
- University of California, San FranciscoRecruiting
- University of Colorado
- Hartford HealthRecruiting
- Yale UniversityRecruiting
- Medstar Health Research InstituteRecruiting
- JFK Medical CenterRecruiting
- HCA Florida Largo Hospital
- University of MiamiRecruiting
- Ascension Sacred Heart
- Tampa General HospitalRecruiting
- Emory UniversityRecruiting
- Piedmont Heart Institute
- Northwestern UniversityRecruiting
- University of Chicago Medical CenterRecruiting
- Advocate Good Samaritan HospitalRecruiting
- Norton Heart Specialists
- Our Lady of the Lake Regional Medical Center
- Cardiovascular Institute of the SouthRecruiting
- Northern Light Eastern Maine Medical CenterRecruiting
- University of Maryland Medical Center
- Massachusetts General HospitalRecruiting
- Beth Israel Deaconess Medical CenterRecruiting
- University of Massachusetts
- University of MichiganRecruiting
- Spectrum HealthRecruiting
- William Beaumont HospitalRecruiting
- Minneapolis Heart Institute FoundationRecruiting
- University of MinnesotaRecruiting
- Jackson Heart ClinicRecruiting
- Washington University in St. LouisRecruiting
- Deborah Heart & Lung
- Hackensack University Medical CenterRecruiting
- Morristown Medical CenterRecruiting
- Montefiore Medical CenterRecruiting
- University at BuffaloRecruiting
- Northwell HealthRecruiting
- Mount Sinai HospitalRecruiting
- CUMC/New York Presbyterian HospitalRecruiting
- Weill Cornell Medicine-New York Presbyterian HospitalRecruiting
- Vassar Brothers Medical CenterRecruiting
- St. Francis HospitalRecruiting
- NC Heart and Vascular Research, LLC
- The Christ HospitalRecruiting
- UH Cleveland Medical Center
- Cleveland ClinicRecruiting
- Ohio State UniversityRecruiting
- INTEGRIS Baptist Medical CenterRecruiting
- Oklahoma Heart HospitalRecruiting
- Oklahoma Heart InstituteRecruiting
- Providence St. Vincent Medical CenterRecruiting
- Oregon Health & Science UniversityRecruiting
- Geisinger Clinic
- Pinnacle Health Cardiovascular InstituteRecruiting
- Penn State Hershey Medical CenterRecruiting
- Thomas Jefferson UniversityRecruiting
- Allegheny General HospitalRecruiting
- UPMC Heart and Vascular InstituteRecruiting
- Rhode Island HospitalRecruiting
- Medical University of South CarolinaRecruiting
- Prisma Health
- Tennova Healthcare-Turkey Creek Medical Center
- Ascension Saint ThomasRecruiting
- Vanderbilt University Medical CenterRecruiting
- Austin HeartRecruiting
- Houston HeartRecruiting
- Baylor College of Medicine St. Luke's Medical CenterRecruiting
- Houston Methodist Hospital
- UT HealthRecruiting
- Texas Tech University Health Sciences CenterRecruiting
- Baylor Scott & White
- Methodist Healthcare System, San AntonioRecruiting
- Intermountain Medical CenterRecruiting
- University of Virginia Health SystemRecruiting
- Sentara Norfolk General HospitalRecruiting
- CJW Chippenham Medical CenterRecruiting
- Carilion Roanoke Memorial HospitalRecruiting
- Valley Health WinchesterRecruiting
- University of Washington
- Providence Sacred Heart Medical CenterRecruiting
- CAMC Clinical Trials Center
- Aurora St. Luke's Medical CenterRecruiting
- Medical College of Wisconsin
- Republican Scientific and Practical Centre of CardiologyRecruiting
- OLV Heart CentreRecruiting
- AZ Sint-Jan-Oostende AV Campus BruggeRecruiting
- St. Anne's University Hospital
- Na Homolce Hospital
- Hôpital de la Timone
- CHU de Rennes - Hôpital Pontchaillou
- Clinique-Pasteur
- St. Antonius Ziekenhuis
- Erasmus Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Device group: AccuCinch Ventricular Restoration System
Control group: Guideline-Directed Medical Therapy
Subjects in this arm will receive the AccuCinch Ventricular Restoration System
Subjects in this arm will receive guideline-directed medical therapy (GDMT)