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

• 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.

Study Timeline

• Study First Submitted: 2018-05-11
• Study First Submitted QC: 2018-05-22
• Study First Posted: 2018-05-23
• Study Start: 2018-08-23
• Primary Completion: 2021-03-26
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30
• Study Completion: 2026-02-28

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

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)

Trial Locations

Locations (18)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Emory University Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

Cardiovascular Institute of the South; 🇺🇸 Houma, Louisiana, United States

Minneapolis Heart Foundation Institute; 🇺🇸 Minneapolis, Minnesota, United States

Nebraska Heart Institute / Nebraska Heart Hospital; 🇺🇸 Lincoln, Nebraska, United States

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States

Mt. Sinai; 🇺🇸 New York, New York, United States

Columbia University Medical Center/NYPH; 🇺🇸 New York, New York, United States

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