Clinical trial NCT03560167: Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients With Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation
Official title: An Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients With Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation - The CorCinch-PMVI Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Cardiomyopathy, Dilated
Lead sponsor: Ancora Heart, Inc.
Sponsor class: INDUSTRY
First posted: 2018-06-18
Enrollment: 5
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 non-randomized, prospective, multi-center Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation.

Detailed description: Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular Restoration System, FDA Approval Date August 14, 2020.

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 Consortium1; and 2003 ASE Guidelines for grading mitral regurgitation2)
* Patient has had a prior surgical or percutaneous mitral repair procedure \>3 months prior to enrollment
* LV Ejection Fraction: ≥20 to ≤40%
* Symptom Status: NYHA II-IV (i.e., ambulatory)
* Prescribed appropriate guideline-directed medical therapy for heart failure for at least 3 months with stable doses of diuretics, beta-blockers and Angiotensin converting enzyme inhibitor (ACEi) or Angiotensin II Receptor Blockers (ARB) for 1 month (with stable defined as no greater than 100% increase of 50% decrease in medication doses). Treatment shall include CRT and/or ICD when indicated by guidelines.
* Able and willing to complete 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 3 months
* Prior surgical, transcatheter, or percutaneous mitral valve replacement
* 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)
* Fixed pulmonary artery systolic pressure \>70 mmHg
* Severe tricuspid regurgitation
* History of stroke within the prior 3 months or any prior stroke with 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 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
* 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

Primary outcomes:
measure: Safety measured by device-related or procedure-related major adverse events (MAEs)
timeFrame: 30-day
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Atlanta
country: United States
facility: Piedmont Heart
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Minneapolis
country: United States
facility: Minneapolis Heart Foundation Institute
state: Minnesota
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Harrisburg
country: United States
facility: PinnacleHealth Cardiovascular Institute
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
city: Austin
country: United States
facility: Austin Heart
state: Texas
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: Virginia Tech Carilion School of Medicine and Research Institute
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medicine
state: Washington
Study officials:
affiliation: Ancora Heart, Inc.
name: Michael Zapien, MS, CCRA
role: STUDY_DIRECTOR
affiliation: Emory University
name: Kendra Grubb, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor St. Luke's Medical Center
name: Guilherme Silva, MD
role: PRINCIPAL_INVESTIGATOR
References: