Early Feasibility Evaluation of the AccuCinch® Ventricular Restoration System in Patients With Heart Failure and Reduced Ejection Fraction
NCT ID: NCT03533517
Last Updated: 2025-01-30
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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ACTIVE_NOT_RECRUITING
NA
22 participants
INTERVENTIONAL
2018-08-23
2026-02-28
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
AccuCinch® Ventricular Restoration System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF)
Interventions
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AccuCinch® Ventricular Restoration
AccuCinch® Ventricular Restoration System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF)
Eligibility Criteria
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Inclusion Criteria
* Ejection Fraction: ≥20 and ≤40%
* LV end-diastolic diameter ≥55 mm
* Symptom Status: NYHA III-IV (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
* Mitral regurgitation grade 3 (moderate-severe) or more
* 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)
* 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 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
* 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
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.
Ulrich Jorde, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center
Azeem Latib, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center
Locations
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University of California, San Francisco
San Francisco, California, United States
Emory University Hospital Midtown
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
Nebraska Heart Institute / Nebraska Heart Hospital
Lincoln, Nebraska, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Mt. Sinai
New York, New York, United States
Columbia University Medical Center/NYPH
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
The Christ Hospital
Cincinnati, Ohio, United States
Pinnacle Health Cardiovascular Institute
Harrisburg, Pennsylvania, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 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
Carilion Roanoke Memorial
Roanoke, Virginia, United States
Countries
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Other Identifiers
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5017
Identifier Type: -
Identifier Source: org_study_id
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