Early Feasibility Study of the AccuCinch® Ventricular Repair System - The CorCinch-FMR Study



Status:Recruiting
Conditions:Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:10/21/2018
Start Date:August 2016
End Date:March 2024
Contact:Michael Zapien, MS, CCRA
Email:mzapien@ancoraheart.com
Phone:408-727-1105

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Early Feasibility Study of the AccuCinch® Ventricular Repair System

This is a multi-center, non-randomized, prospective Early Feasibility Study to evaluate the
AccuCinch® Ventricular Repair System in patients with symptomatic heart failure and
concomitant functional mitral regurgitation that have stable symptoms on guideline-directed
medical therapy


Inclusion Criteria:

- Study patient is an adult of legal consent age.

- Severity of functional mitral regurgitation (FMR): ≥ Moderate (i.e., 2+, according to
2003 ASE Guidelines for grading mitral regurgitation)

- Ejection Fraction: ≥20 to ≤60%

- Symptom Status: New York Heart Association (NYHA) II-IVa (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 millimeter Mercury (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 IVb (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 American Society of Echocardiography (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

- Mitral valve area less than 4.0 centimeter2 (cm2)

- Anatomical pathology/constraints preventing appropriate access/implant of the GDS
AccuCinch System (e.g., femoral arteries will not support an 18 French (Fr) system)

- Renal insufficiency (i.e., estimated glomerular filtration rate (eGFR) of <30
milliliters/minute/meter (ml/min/1.73m2); Stage 4 or 5 chronic kidney disease (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

- History of stroke within the prior 3 months

- Subjects in whom anticoagulation or anti-platelet 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 (cardiac resynchronization therapy
(CRT) or cardiac resynchronization therapy device (CRT-D)) or implantable cardioverter
defibrillator within the prior month

- Absence of CRT with class I indication criteria for biventricular pacing (left bundle
branch block pattern and Q-wave/R-wave/S-wave (QRS) duration ≥150 milliseconds (ms))

- 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
We found this trial at
16
sites
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Giora Weisz, MD
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Kendra Grubb, MD
Phone: 404-712-7623
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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Charlottesville, Virginia 22908
Principal Investigator: Scott Lim, MD
Phone: 434-982-1058
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Charlottesville, VA
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Carlos Ruiz, MD, PhD
Phone: 551-996-5595
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hackensack, NJ
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2808 Old Post Road
Harrisburg, Pennsylvania 17011
Principal Investigator: Hemal Gada, MD
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Harrisburg, PA
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500 University Drive
Hershey, Pennsylvania 17033
Principal Investigator: Pradeep Yadav, MD
Phone: 717-531-5967
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Hershey, PA
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Houston, Texas 77020
Principal Investigator: Guilherme Silva, MD
Phone: 832-355-3710
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Houston, TX
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Lincoln, Nebraska 68526
Principal Investigator: Hosakote Nagaraj, MD
Phone: 402-328-3930
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Lincoln, NE
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
Principal Investigator: Kendra Grubb, MD
Phone: 502-587-4106
University of Louisville The University of Louisville is a state supported research university located in...
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Louisville, KY
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Minneapolis, Minnesota 55407
Principal Investigator: Paul Sorajja, MD
Phone: 612-863-7601
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Minneapolis, MN
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New York, New York 10016
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New York, NY
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Susheel Kodali, MD
Phone: 212-342-3488
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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Roanoke, Virginia 24014
Principal Investigator: Rahul Sharma, MD
Phone: 540-224-6751
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Roanoke, VA
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Saint Louis, Missouri 63110
Principal Investigator: John Lasala, MD, PhD
Phone: 314-747-4452
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Saint Louis, MO
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Salt Lake City, Utah 84157
Principal Investigator: Brian Whisenant, MD
Phone: 801-507-4769
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Salt Lake City, UT
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Seattle, Washington 98104
Phone: 206-221-9154
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Seattle, WA
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