To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)
A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT) Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 5 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,247
Transcatheter mitral valve repair with the Edwards PASCAL System
Transcatheter mitral valve repair with the Abbott Mitraclip System
PASCAL is not inferior to MitraClip with respect to the proportion of patients with major adverse events (MAE). The primary safety endpoint is a composite of Major Adverse Events (MAEs).
Time frame: 30 days.
PASCAL is not inferior to Mitraclip with respect to the proportion of patients with MR severity reduction as measured by echocardiography using a scale of 0-4+ for the CLASP IID Cohort.
Time frame: 6 months
PASCAL is not inferior to Mitraclip with respect to the time to first heart failure hospitalization or death for the CLASP IIF Cohort only.
Time frame: From date of randomization until date of first heart failure hospitalization or death, through 5 year follow-up
Rates of various adverse events
Rates of various adverse events at 6 and 12 months
Time frame: 6 months; 12 months
Functional Improvement (increase in 6 minute walk test in meters)
Increase in 6 minute walk test in meters
Time frame: 30 days , 6 months, 1 year
Functional improvement (quality of life) as assessed using the Kansas City Cardiomyopathy Questionnaire through 2 years
Number of points of improvement on a scale of 0-100 in Kansas City Cardiomyopathy Questionnaire, with higher scores associated with higher Quality of Life
Time frame: 30 days , 6 months, 1 year, 2 year
Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (SF-36) questionnaire through 2 years
Number of points of improvement on a scale of 0-100 in Short Form Health Survey (SF-36) questionnaire, with higher totals associated with higher Quality of Life
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Banner University Medical Center
Phoenix, Arizona, United States
Abrazo Arizona Heart Hospital
Phoenix, Arizona, United States
TMC Healthcare
Tucson, Arizona, United States
Scripps Memorial Hospital La Jolla
La Jolla, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
UC Irvine
Orange, California, United States
Sutter Medical Center-Sacramento
Sacramento, California, United States
Sutter Bay Area
San Francisco, California, United States
Kaiser Permanente San Francisco
San Francisco, California, United States
University of California, San Francisco
San Francisco, California, United States
...and 77 more locations
Time frame: 30 days, 6 months, 1 year, 2 year
Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (EQ-5D-5L) questionnaire through
Number of points of improvement on a scale of 1-100 in Short Form Health Survey (EQ-5D-5L) questionnaire, with higher totals associated with higher Quality of Life
Time frame: 30 days, 6 months, 1 year, 2 year