The CorCinch - Functional Mitral Valve Regurgitation (FMR) Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02806570 |
Recruitment Status :
Active, not recruiting
First Posted : June 20, 2016
Last Update Posted : August 2, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Heart Failure Mitral Valve Insufficiency Cardiomyopathies | Device: Mitral valve repair | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 35 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Device Feasibility |
Official Title: | Early Feasibility Study of the AccuCinch® Ventricular Restoration System |
Actual Study Start Date : | August 2016 |
Actual Primary Completion Date : | January 2020 |
Estimated Study Completion Date : | March 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: AccuCinch® Ventricular Restoration System |
Device: Mitral valve repair |
- 30-Day Safety [ Time Frame: 30-day ]
Assess 30-day safety defined as device-related or procedure-related major adverse events (MAEs).
MAE is a composite of death; myocardial infarction; emergent conversion to surgery; stroke; major cardiac structure complication; major vascular complication; and heart failure-related hospitalization.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02806570
United States, Georgia | |
Emory University | |
Atlanta, Georgia, United States, 30322 | |
United States, Kentucky | |
University of Louisville | |
Louisville, Kentucky, United States, 40202 | |
United States, Minnesota | |
Minneapolis Heart Foundation Institute | |
Minneapolis, Minnesota, United States, 55407 | |
United States, Nebraska | |
Nebraska Heart Institute / Nebraska Heart Hospital | |
Lincoln, Nebraska, United States, 68526 | |
United States, New Jersey | |
Hackensack University Medical Center | |
Hackensack, New Jersey, United States, 07601 | |
United States, New York | |
Montefiore Medical Center | |
Bronx, New York, United States, 10467 | |
NYU Langone Medical Center | |
New York, New York, United States, 10016 | |
Columbia University Medical Center | |
New York, New York, United States, 10032 | |
United States, Ohio | |
The Christ Hospital | |
Cincinnati, Ohio, United States | |
United States, Pennsylvania | |
Pinnacle Health Cardiovascular Institute | |
Harrisburg, Pennsylvania, United States, 17101 | |
Penn State Health Milton S. Hershey Medical Center | |
Hershey, Pennsylvania, United States, 17033 | |
United States, Texas | |
Baylor College of Medicine St. Luke's Medical Center | |
Houston, Texas, United States, 77020 | |
United States, Utah | |
Intermountain Medical Center | |
Salt Lake City, Utah, United States, 84109 | |
United States, Virginia | |
University of Virginia School of Medicine | |
Charlottesville, Virginia, United States, 22908 | |
Carilion Medical Center | |
Roanoke, Virginia, United States, 24014 | |
United States, Washington | |
University of Washington Medicine | |
Seattle, Washington, United States, 98195 |
Study Director: | Michael Zapien, MS, CCRA | Ancora Heart, Inc. (formerly Guided Delivery Systems Inc.) | |
Principal Investigator: | Dean Kereiakes, MD | The Christ Hospital | |
Principal Investigator: | Satya Shreenivas, MD | The Christ Hospital |
Responsible Party: | Ancora Heart, Inc. |
ClinicalTrials.gov Identifier: | NCT02806570 |
Other Study ID Numbers: |
4433 |
First Posted: | June 20, 2016 Key Record Dates |
Last Update Posted: | August 2, 2021 |
Last Verified: | July 2021 |
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 |
Cardiomyopathies Mitral Valve Insufficiency Heart Diseases Cardiovascular Diseases Heart Valve Diseases |