Status
Conditions
Treatments
About
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).
Full 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:
Enrollment
Sex
Ages
Volunteers
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:
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.
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
Primary purpose
Allocation
Interventional model
Masking
400 participants in 2 patient groups
Loading...
Central trial contact
Michael Zapien, MS, CCRA
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal