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

• ClinicalTrials.gov Identifier: NCT03560167
• Recruitment Status: Active, not recruiting
• First Posted: June 18, 2018
• Last Update Posted: October 26, 2020
• Sponsor: Ancora Heart, Inc.
• Information provided by (Responsible Party): Ancora Heart, Inc.

Tracking Information

• First Submitted Date: June 6, 2018
• First Posted Date: June 18, 2018
• Last Update Posted Date: October 26, 2020
• Actual Study Start Date: September 24, 2018
• Estimated Primary Completion Date: October 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 25, 2018)

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)

• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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
• Brief Summary: This is a non-randomized, prospective, multi-center Early Feasibility Study of the AccuCinch® Ventricular Repair 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Heart Failure
• Cardiomyopathy, Dilated

Intervention

Device: AccuCinch® Ventricular Repair

AccuCinch® Ventricular Repair System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation

Study Arms

Experimental: AccuCinch® Ventricular Repair System

Intervention: Device: AccuCinch® Ventricular Repair

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: July 25, 2018): 15
• Original Enrollment: Not Provided
• Estimated Study Completion Date: December 30, 2024
• Estimated Primary Completion Date: October 30, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03560167
• Other Study ID Numbers: 5018
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

• IPD Sharing Statement: Not Provided
• Responsible Party: Ancora Heart, Inc.
• Study Sponsor: Ancora Heart, Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Michael Zapien, MS, CCRA; Ancora Heart, Inc.
• Principal Investigator: Kendra Grubb, MD; Emory University
• Principal Investigator: Guilherme Silva, MD; Baylor / St. Luke's Medical Center

• PRS Account: Ancora Heart, Inc.
• Verification Date: October 2020