Early Feasibility Evaluation of the AccuCinch® Ventricular Restoration System in Patients With Heart Failure and Reduced Ejection Fraction
Purpose
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).
Conditions
- Heart Failure
- Cardiomyopathy, Dilated
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Device Feasibility
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental AccuCinch® Ventricular Restoration System |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Ancora Heart, Inc.
Study Contact
Detailed Description
Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular Restoration System, FDA Approval Date 08Aug2020.