Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients With Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation
NCT ID: NCT03560167
Last Updated: 2024-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
5 participants
INTERVENTIONAL
2018-09-24
2024-01-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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AccuCinch® Ventricular Restoration System
AccuCinch® Ventricular Restoration System
AccuCinch® Ventricular Restoration System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation
Interventions
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AccuCinch® Ventricular Restoration System
AccuCinch® Ventricular Restoration System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Ancora Heart, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Zapien, MS, CCRA
Role: STUDY_DIRECTOR
Ancora Heart, Inc.
Kendra Grubb, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Guilherme Silva, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor St. Luke's Medical Center
Locations
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University of California, San Francisco
San Francisco, California, United States
Piedmont Heart
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
University of Louisville
Louisville, Kentucky, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
Minneapolis Heart Foundation Institute
Minneapolis, Minnesota, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Mount Sinai
New York, New York, United States
The Christ Hospital
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
PinnacleHealth Cardiovascular Institute
Harrisburg, Pennsylvania, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Austin Heart
Austin, Texas, United States
Baylor College of Medicine St. Luke's Medical Center
Houston, Texas, United States
Intermountain Medical Center
Salt Lake City, Utah, United States
University of Virginia School of Medicine
Charlottesville, Virginia, United States
Virginia Tech Carilion School of Medicine and Research Institute
Roanoke, Virginia, United States
University of Washington Medicine
Seattle, Washington, United States
Countries
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Other Identifiers
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5018
Identifier Type: -
Identifier Source: org_study_id
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