Early Feasibility Evaluation of the AccuCinch® Ventricular Restoration System in Patients With Heart Failure and Reduced Ejection Fraction (CorCinch-HFrEF)

Ancora Heart

Status

Active, not recruiting

Conditions

Cardiomyopathy, Dilated

Heart Failure

Treatments

Device: AccuCinch® Ventricular Restoration

Study type

Interventional

Funder types

Industry

Identifiers

NCT03533517

5017

Details and patient eligibility

About

This is a non-randomized, prospective, multi-center Early Feasibility Study to evaluate the AccuCinch® Ventricular Restoration System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF).

Full description

Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular Restoration System, FDA Approval Date 08Aug2020.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Study patient is at least 18-years old
Ejection Fraction: ≥20 and ≤40%
LV end-diastolic diameter ≥55 mm
Symptom Status: NYHA III-IV (i.e., ambulatory)
Treatment and compliance with optimal guideline directed medical and device-based therapies for heart failure (unless contraindicated or intolerant) for at least 3 months and stable doses for 1 month with stable defined as no more than 100% increase or 50% decrease of total daily doses.
Patients with left bundle branch block pattern and QRS duration >150ms are required to have a CRT device for at least 3 months
Patients required to have an ICD are required to have ICD implant at least 1 month prior to enrollment
Able and willing to complete all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule

Exclusion criteria

Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 3 months
Mitral regurgitation grade 3 (moderate-severe) or more
Prior surgical, transcatheter, or percutaneous mitral valve intervention
Untreated clinically significant coronary artery disease (CAD) requiring revascularization
Hemodynamic instability: Hypotension (systolic pressure <90 mmHg) or requirement for inotropic support or mechanical hemodynamic support
Any planned cardiac surgery or interventions within the next 6 months (including right heart procedures)
NYHA class IV (i.e., non-ambulatory)
Significant RV dysfunction (TAPSE < 14)
Severe tricuspid regurgitation
Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology
Anatomical pathology or constraints preventing appropriate access/implant of the AccuCinch® Ventricular Repair System (e.g., femoral arteries will not support a 20F system)
Renal insufficiency (i.e., eGFR of <30ml/min/1.73m2; Stage 4 or 5 CKD)
Moderate or severe aortic valve stenosis or regurgitation or aortic valve prosthesis
Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation
Active bacterial endocarditis
History of any stroke within the prior 3 months or Modified Rankin Scale ≥ 4 disability from any prior stroke
Subjects in whom anticoagulation or 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.
Life expectancy < 1 year due to non-cardiac conditions
Currently participating in another interventional investigational study
Implant or revision of any rhythm management device (CRT or CRT-D) prior 3 months or implantable cardioverter defibrillator within the prior 1 month
Subjects on high dose steroids or immunosuppressant therapy
Female subjects who are pregnant, of child bearing potential without a documented birth control method, or lactating