Clinical Study of the Edwards Cardioband FIT Repair System
The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards Cardioband FIT Repair System
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Repair of the tricuspid valve through a transcatheter approach
Northwestern University
Chicago, Illinois, United States
Mayo Clinic
Rochester, Minnesota, United States
Morristown Medical Center
Morristown, New Jersey, United States
Columbia University Medical Center /New York Presbyterian Hospital
Primary Safety Endpoint -Composite Major Adverse Event (MAE) Rate
Number and percentage of patients who experienced at least one major adverse event (MAE).
Time frame: 30 days
Primary Performance Endpoint - Intraprocedural Success
Number of patients who had Intraprocedural Success, definition modified from TVARC criteria. Per patient analysis.
Time frame: Intraprocedural
Primary Performance Endpoint - Clinical Success
Number of patients who had Clinical Success at 30 days and 1 year, definition modified from TVARC criteria. Per patient analysis.
Time frame: 30 days and 1 year
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New York, New York, United States
Oregon Health & Science University
Portland, Oregon, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Heart Hospital Baylor Plano
Plano, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States