The purpose of this study is to determine the safety and effectiveness of the device and delivery systems (transfemoral and transapical) in high risk, symptomatic patients with severe aortic stenosis.
Subjects will undergo a physical exam and screening tests will be performed to determine if they are either A) a patient with a high surgical risk or B) not a candidate for surgery. They will then be randomized (like the flip of a coin) to have the investigational device implanted or to receive the current surgical or medical management available.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,057
Scripps Memorial Hospital/Scripps Green Hospital
Death
Death from any cause.
Time frame: 1 Year
Composite of Death and Recurrence Hospitalization.
Death from any cause or repeat hospitalization after intervention.
Time frame: duration of study
Functional Change of NYHA
NYHA classification change from baseline to 1 year visit. NYHA provides a way of classifying the extent of heart failure. New York Heart Association (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: Baseline to 1 year
Number of Participants With Major Adverse Cardiac and Cerebro-vascular Events (MACCE)
Number of participants with MACCE definition includes death, myocardial infarction (MI), stroke and renal failure
Time frame: 1 year
Total Hospital Days From the Index Procedure
Total hospital days from the index procedure or randomization into control arm to one year post procedure or randomization.
Time frame: 1 year
Change in Quality of Life (QOL) From Baseline to 1 Year
The QOL questionnaire consisted of: Kansas City Cardiomyopathy (KCCQ), The Medical Outcomes Study Short-Form 12 (SF-12) - physical and metal states. KCCQ scores are on a range of 0-100, in which 100 reflects the best health status and 0 reflects the worst health status. SF-12 questionnaire was used in which 100 reflects the best health status and 0 reflects the worst health status.
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La Jolla, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Stanford University Medical Center
Stanford, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
University of Miami
Miami, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
Ochsner Clinic
New Orleans, Louisiana, United States
Boston Mass General
Boston, Massachusetts, United States
...and 16 more locations
Time frame: Baseline and 1 Year