- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03560167
Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients With Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation (CorCinch-PMVI)
April 11, 2023 updated by: Ancora Heart, Inc.
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
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular Restoration System, FDA Approval Date August 14, 2020.
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 94143
- University of California, San Francisco
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Emory University
-
Atlanta, Georgia, United States, 30309
- Piedmont Heart
-
-
Kentucky
-
Louisville, Kentucky, United States, 40202
- University of Louisville
-
-
Louisiana
-
Houma, Louisiana, United States, 70360
- Cardiovascular Institute of the South
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55407
- Minneapolis Heart Foundation Institute
-
-
New Jersey
-
Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center
-
-
New York
-
New York, New York, United States, 10029
- Mount Sinai
-
-
Ohio
-
Cincinnati, Ohio, United States, 45219
- The Christ Hospital
-
Cleveland, Ohio, United States, 44106
- University Hospitals Cleveland Medical Center
-
-
Oklahoma
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Oklahoma City, Oklahoma, United States, 73120
- Oklahoma Heart Hospital
-
-
Pennsylvania
-
Harrisburg, Pennsylvania, United States, 17101
- PinnacleHealth Cardiovascular Institute
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Hershey, Pennsylvania, United States, 17033
- Penn State Health Milton S. Hershey Medical Center
-
-
Texas
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Austin, Texas, United States, 78756
- Austin Heart
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Houston, Texas, United States, 77020
- Baylor College of Medicine St. Luke's Medical Center
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-
Utah
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Salt Lake City, Utah, United States, 84109
- Intermountain Medical Center
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Virginia
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Charlottesville, Virginia, United States, 22908
- University Of Virginia School of Medicine
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Roanoke, Virginia, United States, 24014
- Virginia Tech Carilion School of Medicine and Research Institute
-
-
Washington
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Seattle, Washington, United States, 98195
- University of Washington Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AccuCinch® Ventricular Restoration System
|
AccuCinch® Ventricular Restoration System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
30-day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kendra Grubb, MD, Emory University
- Principal Investigator: Guilherme Silva, MD, Baylor St. Luke's Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 24, 2018
Primary Completion (Actual)
March 25, 2021
Study Completion (Anticipated)
December 30, 2024
Study Registration Dates
First Submitted
June 6, 2018
First Submitted That Met QC Criteria
June 6, 2018
First Posted (Actual)
June 18, 2018
Study Record Updates
Last Update Posted (Actual)
April 13, 2023
Last Update Submitted That Met QC Criteria
April 11, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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