Early Feasibility Evaluation of the AccuCinch® Ventricular Restoration System in Patients With Heart Failure and Reduced Ejection Fraction
- Conditions
- Heart FailureCardiomyopathy, 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
- 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
- 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
Group Intervention Description AccuCinch® Ventricular Restoration System AccuCinch® Ventricular Restoration -
- Primary Outcome Measures
Name Time Method 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
Name Time Method
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