This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.
This is a prospective, single-arm, multicenter study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
125
Edwards SAPIEN 3/SAPIEN 3 Ultra THV system with the associated delivery systems.
Safety and Effectiveness - Non-hierarchical composite of all-cause mortality and stroke
Number of patients that died and/or had a stroke
Time frame: 1 year
Mean gradient
Measures the mean aortic pressure gradient from the measured velocity. Units used are mmHg.
Time frame: 30 days
Peak gradient
Measures the peak aortic pressure gradient from the measured velocity. Units used are mmHg.
Time frame: 30 days
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Change from baseline in KCCQ. The KCCQ is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life.
Time frame: 30 days
New York Heart Association (NYHA) Classification
Change from baseline in NYHA. 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.
Time frame: 30 days
Six-Minute Walk Test (6MWT)
Change from baseline in 6MWT. The 6-Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Time frame: 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Banner University Medical Center
Phoenix, Arizona, United States
RECRUITINGUniversity of California Los Angeles
Los Angeles, California, United States
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Sacramento, California, United States
RECRUITINGKaiser Permanente San Francisco
San Francisco, California, United States
WITHDRAWNStanford University Medical Center
Stanford, California, United States
RECRUITINGUC Health Northern Colorado/Medical Center of the Rockies
Loveland, Colorado, United States
RECRUITINGHartford Hospital
Hartford, Connecticut, United States
RECRUITINGJFK Medical Center/ Atlantic Clinical Research Collaborative
Atlantis, Florida, United States
WITHDRAWNUniversity of Florida, Gainesville
Gainesville, Florida, United States
WITHDRAWNEmory University Hospital
Atlanta, Georgia, United States
RECRUITING...and 41 more locations