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Active, not recruiting Not applicable

Early Feasibility Evaluation of the AccuCinch® Ventricular Restoration System in Patients With Heart Failure and Reduced Ejection Fraction

NCT03533517 · tracked via the Priya Life Science USA tracker
Sponsor
Ancora Heart, Inc
Phase
Not applicable
Started
2018-08-23
Last updated
2025-01-30

Condition(s) studied

Heart FailureCardiomyopathy, Dilated

Investigational drug(s) / intervention(s)

AccuCinch® Ventricular Restoration

AccuCinch® Ventricular Restoration: AccuCinch® Ventricular Restoration System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF)

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • Safety measured by device-related or procedure-related major adverse events (MAEs) — 30-day
    Device-related or procedure-related major adverse events (MAEs)

Trial sites (18)

FacilityCityRegionStatus
University of California, San Francisco San Francisco California
Emory University Hospital Midtown Atlanta Georgia
University of Louisville Louisville Kentucky
Cardiovascular Institute of the South Houma Louisiana
Minneapolis Heart Foundation Institute Minneapolis Minnesota
Nebraska Heart Institute / Nebraska Heart Hospital Lincoln Nebraska
Hackensack University Medical Center Hackensack New Jersey
Mt. Sinai New York New York
Columbia University Medical Center/NYPH New York New York
Montefiore Medical Center The Bronx New York
The Christ Hospital Cincinnati Ohio
Pinnacle Health Cardiovascular Institute Harrisburg Pennsylvania
Penn State Health Milton S. Hershey Medical Center Hershey Pennsylvania
University of Pennsylvania Philadelphia Pennsylvania
Baylor College of Medicine St. Luke's Medical Center Houston Texas
Intermountain Medical Center Salt Lake City Utah
University of Virginia School of Medicine Charlottesville Virginia
Carilion Roanoke Memorial Roanoke Virginia
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03533517 on ClinicalTrials.gov ↗ ← All trials in the USA