Clinical trial NCT02806570: The CorCinch - Functional Mitral Valve Regurgitation (FMR) Study
Official title: Early Feasibility Study of the AccuCinch® Ventricular Restoration System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Mitral Valve Insufficiency
Cardiomyopathies
Lead sponsor: Ancora Heart, Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-20
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This is a multi-center, non-randomized, prospective Early Feasibility Study to evaluate the AccuCinch® Ventricular Restoration System in patients with symptomatic heart failure and concomitant functional mitral regurgitation that have stable symptoms on guideline-directed medical therapy

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

Eligibility criteria: Inclusion Criteria:

* Study patient is at least 18-years old
* Severity of FMR: ≥ Moderate (i.e., 2+, according to Stone et al Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 1: Clinical Trial Design Principles. A Consensus Document from the Mitral Valve Academic Research Consortium11; and 2003 ASE Guidelines for grading mitral regurgitation10)
* Ejection Fraction: ≥20 to ≤60%
* Symptom Status: NYHA II-IV (i.e., ambulatory)
* Treatment and compliance with optimal guideline directed medical therapy for heart failure for at least 1 month
* Surgical risk: Subject is eligible for cardiac surgery (specific risk score or comorbidities should demonstrate high risk features, as determined by the Heart Team)
* Completion of all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule

Exclusion Criteria:

* Patients with significant organic mitral valve pathology (e.g. myxomatous degeneration, mitral valve prolapse or flail leaflets)
* Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days
* 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) or American College of Cardiology (ACC)/American Heart Association (AHA) Stage D heart failure
* Fixed pulmonary artery systolic pressure \>70 mmHg
* Severe tricuspid regurgitation (per ASE guidelines and graded by the Echo Core Lab)
* Modified Rankin Scale ≥ 4 disability
* 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/constraints preventing appropriate access/implant of the AccuCinch® Ventricular Restoration 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

Primary outcomes:
measure: 30-Day Safety
timeFrame: 30-day
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Minneapolis
country: United States
facility: Minneapolis Heart Foundation Institute
state: Minnesota
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Lincoln
country: United States
facility: Nebraska Heart Institute / Nebraska Heart Hospital
state: Nebraska
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Harrisburg
country: United States
facility: Pinnacle Health Cardiovascular Institute
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine St. Luke's Medical Center
state: Texas
city: Salt Lake City
country: United States
facility: Intermountain Medical Center
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia School of Medicine
state: Virginia
city: Roanoke
country: United States
facility: Carilion Medical Center
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medicine
state: Washington
Study officials:
affiliation: Ancora Heart, Inc. (formerly Guided Delivery Systems Inc.)
name: Michael Zapien, MS, CCRA
role: STUDY_DIRECTOR
affiliation: The Christ Hospital
name: Dean Kereiakes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Christ Hospital
name: Satya Shreenivas, MD
role: PRINCIPAL_INVESTIGATOR
References: