An Early Feasibility Evaluation of the AccuCinch® Ventricular Repair System in Patients With Heart Failure and Reduced Ejection Fraction (HFrEF) - The CorCinch-HFrEF 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 23, 2018
End Date:July 31, 2024
Contact:Michael Zapien, MS, CCRA
Email:mzapien@ancoraheart.com
Phone:4087271105

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This is a non-randomized, prospective, multi-center Early Feasibility Study to evaluate the
AccuCinch® Ventricular Repair System in Patients with Heart Failure and Reduced Ejection
Fraction (HFrEF).


Inclusion Criteria:

- Study patient is at least 18-years old

- Ejection Fraction: ≥20 and ≤40%

- LV end-diastolic diameter ≥55 mm

- Symptom Status: NYHA III-IVa (i.e., ambulatory)

- Treatment and compliance with optimal guideline directed medical and device-based
therapies for heart failure (unless contraindicated or intolerant) for at least 3
months and stable doses for 1 month with stable defined as no more than 100% increase
or 50% decrease of total daily doses.

- Patients with left bundle branch block pattern and QRS duration >150ms are required to
have a CRT device for at least 3 months

- Patients required to have an ICD are required to have ICD implant at least 1 month
prior to enrollment

- 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

- Mitral regurgitation grade 3 (moderate-severe) or more

- 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 IVb (i.e., non-ambulatory)

- Significant RV dysfunction (TAPSE < 14)

- Severe tricuspid regurgitation

- 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 an 20F
system)

- 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 any stroke within the prior 3 months or Modified Rankin Scale ≥ 4
disability from any prior stroke

- 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
We found this trial at
15
sites
Seattle, Washington 98104
Phone: 206-221-9154
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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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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Howard Herrmann, MD
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Philadelphia, PA
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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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2808 Old Post Road
Harrisburg, Pennsylvania 17011
Principal Investigator: Hemal Gada, MD
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500 University Drive
Hershey, Pennsylvania 17033
Principal Investigator: Pradeep Yadav, MD
Phone: 717-531-5825
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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: Steve Martin, 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: Mark Slaughter, MD
Phone: 502-587-4106
University of Louisville The University of Louisville is a state supported research university located in...
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Minneapolis, Minnesota 55407
Principal Investigator: Paul Sorajja, MD
Phone: 612-863-7601
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New York, New York 10029
Principal Investigator: Vivek Reddy, MD
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New York, New York 10032
Principal Investigator: Susheel Kodali, MD
Phone: 212-342-3488
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2 Riverside Circle
Roanoke, Virginia 24014
Principal Investigator: Jason Foerst, MD
Phone: 540-266-6658
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Salt Lake City, Utah 84157
Principal Investigator: Brian Whisenant, MD
Phone: 801-507-4769
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