To assess the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing mitral bioprosthetic valve.
A prospective, single-arm, multicenter clinical trial. This study will enroll patients with symptomatic heart disease due to a failing bioprosthetic mitral valve (stenosed, insufficient, or combined).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Edwards SAPIEN 3 THV system Model 9600TFX with the associated delivery systems.
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Northshore University Health System Research Institution
Evanston, Illinois, United States
Safety and Effectiveness - Composite of All-cause Mortality and Stroke
Non-hierarchical composite endpoint of all-cause mortality and stroke at 1-year post-procedure
Time frame: 1 Year
New York Heart Association (NYHA) Functional Class - Change From Baseline
NYHA is a functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort. A decrease in NYHA class (negative value) shows patient improvement at 30 days.
Time frame: 30 Days
Kansas City Cardiomyopathy Questionnaire (KCCQ) - Change From Baseline
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom, social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. An increase in KCCQ score (positive value) shows patient improvement at 30 days.
Time frame: 30 days
Mitral Regurgitation - Change From Baseline
Echocardiographic assessment of the degree of mitral valve regurgitation None=0, Trace=0.5, Mild or Mild-Moderate=1, Moderate=2, Moderate-Severe=3, and Severe=4. A decrease in MR (negative value) shows patient improvement at 30 days.
Time frame: 30 days
Pulmonary Artery Systolic Pressure - Change From Baseline
Echocardiographic assessment of pulmonary artery systolic pressure A decrease in pulmonary artery systolic pressure (negative value) shows patient improvement at 30 days.
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Barnes-Jewish Hospital/ Washington University
St Louis, Missouri, United States
NYU Lagone Medical Center
New York, New York, United States
Providence Heart & Vascular Institution
Portland, Oregon, United States
The Heart Hospital of Baylor Plano
Plano, Texas, United States
The Prince Charles Hospital
Chermside, Queensland, Australia
...and 2 more locations
Time frame: 30 days