This is a non-randomized, prospective, multi-center Early Feasibility Study to evaluate the AccuCinch® Ventricular Restoration System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF).
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
22
AccuCinch® Ventricular Restoration System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF)
University of California, San Francisco
San Francisco, California, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Safety measured by device-related or procedure-related major adverse events (MAEs)
Device-related or procedure-related major adverse events (MAEs)
Time frame: 30-day
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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
...and 8 more locations