This is a multi-center, non-randomized, prospective Early Feasibility Study to evaluate the AccuCinch® Ventricular Restoration System in patients with symptomatic heart failure and concomitant functional mitral regurgitation that have stable symptoms on guideline-directed medical therapy
Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular Restoration System, FDA Approval Date 08Aug2020
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
35
Emory University
Atlanta, Georgia, United States
University of Louisville
Louisville, Kentucky, United States
30-Day Safety
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.
Time frame: 30-day
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Minneapolis Heart Foundation Institute
Minneapolis, Minnesota, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Nebraska Heart Institute / Nebraska Heart Hospital
Lincoln, Nebraska, United States
NYU Langone Medical Center
New York, New York, United States
Columbia University Medical Center
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
...and 6 more locations