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

Sponsor
Ancora Heart, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03533517
Collaborator
(none)
22
22
1
95.2
1
0

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: AccuCinch® Ventricular Restoration
N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
An Early Feasibility Evaluation of the AccuCinch® Ventricular Restoration System in Patients With Heart Failure and Reduced Ejection Fraction (HFrEF) - The CorCinch-HFrEF Study
Actual Study Start Date :
Aug 23, 2018
Actual Primary Completion Date :
Mar 26, 2021
Anticipated Study Completion Date :
Jul 31, 2026

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Safety measured by device-related or procedure-related major adverse events (MAEs) [30-day]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California, San Francisco San Francisco California United States 94143
2 Emory University Hospital Midtown Atlanta Georgia United States 30308
3 Piedmont Heart Institute Atlanta Georgia United States 30309
4 University of Louisville Louisville Kentucky United States 40202
5 Cardiovascular Institute of the South Houma Louisiana United States 70360
6 Minneapolis Heart Foundation Institute Minneapolis Minnesota United States 55407
7 Nebraska Heart Institute / Nebraska Heart Hospital Lincoln Nebraska United States 68526
8 Hackensack University Medical Center Hackensack New Jersey United States 07601
9 Montefiore Medical Center Bronx New York United States 10467
10 Mt. Sinai New York New York United States 10029
11 Columbia University Medical Center/NYPH New York New York United States 10032
12 The Christ Hospital Cincinnati Ohio United States 45219
13 University Hospitals of Cleveland Cleveland Ohio United States 44106
14 Pinnacle Health Cardiovascular Institute Harrisburg Pennsylvania United States 17101
15 Penn State Health Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033
16 University of Pennsylvania Philadelphia Pennsylvania United States 19104
17 Austin Heart Austin Texas United States 78756
18 Baylor College of Medicine St. Luke's Medical Center Houston Texas United States 77020
19 Intermountain Medical Center Salt Lake City Utah United States 84109
20 University of Virginia School of Medicine Charlottesville Virginia United States 22908
21 Carilion Roanoke Memorial Roanoke Virginia United States 24014
22 University of Washington Medicine Seattle Washington United States 98195

Sponsors and Collaborators

  • Ancora Heart, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ancora Heart, Inc.
ClinicalTrials.gov Identifier:
NCT03533517
Other Study ID Numbers:
  • 5017
First Posted:
May 23, 2018
Last Update Posted:
Mar 16, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2022