MedPath

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

Not Applicable
Active, not recruiting
Conditions
Heart Failure
Cardiomyopathy, Dilated
Interventions
Device: AccuCinch® Ventricular Restoration
Registration Number
NCT03533517
Lead Sponsor
Ancora Heart, Inc.
Brief 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).

Detailed Description

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

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
22
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

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
AccuCinch® Ventricular Restoration SystemAccuCinch® Ventricular Restoration-
Primary Outcome Measures
NameTimeMethod
Safety measured by device-related or procedure-related major adverse events (MAEs)30-day

Device-related or procedure-related major adverse events (MAEs)

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (18)

Carilion Roanoke Memorial

🇺🇸

Roanoke, Virginia, United States

University of Virginia School of Medicine

🇺🇸

Charlottesville, Virginia, United States

Minneapolis Heart Foundation Institute

🇺🇸

Minneapolis, Minnesota, United States

Baylor College of Medicine St. Luke's Medical Center

🇺🇸

Houston, Texas, United States

University of California, San Francisco

🇺🇸

San Francisco, California, United States

Intermountain Medical Center

🇺🇸

Salt Lake City, Utah, United States

University of Louisville

🇺🇸

Louisville, Kentucky, United States

Emory University Hospital Midtown

🇺🇸

Atlanta, Georgia, United States

Cardiovascular Institute of the South

🇺🇸

Houma, Louisiana, United States

Nebraska Heart Institute / Nebraska Heart Hospital

🇺🇸

Lincoln, Nebraska, United States

Hackensack University Medical Center

🇺🇸

Hackensack, New Jersey, United States

Mt. Sinai

🇺🇸

New York, New York, United States

Columbia University Medical Center/NYPH

🇺🇸

New York, New York, United States

The Christ Hospital

🇺🇸

Cincinnati, Ohio, United States

Penn State Health Milton S. Hershey Medical Center

🇺🇸

Hershey, Pennsylvania, United States

Pinnacle Health Cardiovascular Institute

🇺🇸

Harrisburg, Pennsylvania, United States

University of Pennsylvania

🇺🇸

Philadelphia, Pennsylvania, United States

Montefiore Medical Center

🇺🇸

Bronx, New York, United States

© Copyright 2025. All Rights Reserved by MedPath