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

Heart Failure Clinical Trial

— CorCinch-HFrEF  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03533517
• Other study ID #: 5017
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 23, 2018
• Est. completion date: July 31, 2026

Study information

• Verified date: July 2023
• Source: Ancora Heart, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: July 31, 2026
• Est. primary completion date: March 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	Montefiore Medical Center	Bronx	New York
United States	University of Virginia School of Medicine	Charlottesville	Virginia
United States	The Christ Hospital	Cincinnati	Ohio
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Pinnacle Health Cardiovascular Institute	Harrisburg	Pennsylvania
United States	Penn State Health Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	Baylor College of Medicine St. Luke's Medical Center	Houston	Texas
United States	Nebraska Heart Institute / Nebraska Heart Hospital	Lincoln	Nebraska
United States	University of Louisville	Louisville	Kentucky
United States	Minneapolis Heart Foundation Institute	Minneapolis	Minnesota
United States	Columbia University Medical Center/NYPH	New York	New York
United States	Mt. Sinai	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Carilion Roanoke Memorial	Roanoke	Virginia
United States	Intermountain Medical Center	Salt Lake City	Utah
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Ancora Heart, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measured by device-related or procedure-related major adverse events (MAEs)	Device-related or procedure-related major adverse events (MAEs)	30-day