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

NCT03533517 | Active Not Recruiting FDA Device

• 1 other identifier: 5017
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 18

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).

Conditions

Heart Failure; Cardiomyopathy, Dilated

Outcome Measures

Primary Outcomes (1)

• Safety measured by device-related or procedure-related major adverse events (MAEs)

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

  30-day

Study Arms (1)

AccuCinch® Ventricular Restoration System

EXPERIMENTAL

Device: AccuCinch® Ventricular Restoration

Interventions

AccuCinch® Ventricular Restoration DEVICE

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

AccuCinch® Ventricular Restoration System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ancora Heart, Inc.: lead

Study Sites (18)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

Minneapolis Heart Foundation Institute

Minneapolis, Minnesota, 55407, United States

Location

Nebraska Heart Institute / Nebraska Heart Hospital

Lincoln, Nebraska, 68526, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Mt. Sinai

New York, New York, 10029, United States

Location

Columbia University Medical Center/NYPH

New York, New York, 10032, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Pinnacle Health Cardiovascular Institute

Harrisburg, Pennsylvania, 17101, United States

Location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Baylor College of Medicine St. Luke's Medical Center

Houston, Texas, 77020, United States

Location

Intermountain Medical Center

Salt Lake City, Utah, 84109, United States

Location

University of Virginia School of Medicine

Charlottesville, Virginia, 22908, United States

Location

Carilion Roanoke Memorial

Roanoke, Virginia, 24014, United States

Location

MeSH Terms

Conditions

Heart Failure; Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cardiomegaly; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Michael Zapien, MS, CCRA

  Ancora Heart, Inc.

  STUDY DIRECTOR

• Ulrich Jorde, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

• Azeem Latib, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2018
• First Posted: May 23, 2018
• Study Start: August 23, 2018
• Primary Completion: March 26, 2021
• Study Completion: February 28, 2026
• Last Updated: January 30, 2025

Record last verified: 2025-01

Locations

US (18)