Early Feasibility Evaluation of the AccuCinch® Ventricular Restoration System in Patients With Heart Failure and Reduced Ejection Fraction (CorCinch-HFrEF)

July 19, 2023 updated by: Ancora Heart, Inc.

An Early Feasibility Evaluation of the AccuCinch® Ventricular Restoration System in Patients With Heart Failure and Reduced Ejection Fraction (HFrEF) - The CorCinch-HFrEF Study

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University Hospital Midtown
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • Cardiovascular Institute of the South
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Foundation Institute
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Nebraska Heart Institute / Nebraska Heart Hospital
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • New York, New York, United States, 10032
        • Columbia University Medical Center/NYPH
      • New York, New York, United States, 10029
        • Mt. Sinai
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17101
        • Pinnacle Health Cardiovascular Institute
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Health Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Texas
      • Houston, Texas, United States, 77020
        • Baylor College of Medicine St. Luke's Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 84109
        • Intermountain Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia School of Medicine
      • Roanoke, Virginia, United States, 24014
        • Carilion Roanoke Memorial

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AccuCinch® Ventricular Restoration System
Device: AccuCinch® Ventricular Restoration
AccuCinch® Ventricular Restoration System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety measured by device-related or procedure-related major adverse events (MAEs)
Time Frame: 30-day
Device-related or procedure-related major adverse events (MAEs)
30-day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ancora Heart, Inc.

Investigators

  • Principal Investigator: Ulrich Jorde, MD, Montefiore Medical Center
  • Principal Investigator: Azeem Latib, MD, Montefiore Medical Center
  • Study Director: Michael Zapien, MS, CCRA, Ancora Heart, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2018

Primary Completion (Actual)

March 26, 2021

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

May 11, 2018

First Submitted That Met QC Criteria

May 22, 2018

First Posted (Actual)

May 23, 2018

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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