The objective of this study is to determine the safety and efficacy of transcatheter aortic valve replacement (TAVR) via a transfemoral approach in HF patients with moderate AS as compared with OHFT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
178
All-Cause Death
Hierarchical occurrence within efficacy assessment time interval (EATI) of:
Time frame: 12 months
Disabling Stroke
Hierarchical occurrence within efficacy assessment time interval (EATI) of:
Time frame: 12 months
Hospitalizations related to heart failure, symptomatic aortic valve disease or non-disabling stroke -or - Clinically significant worsening of heart failure (heart failure hospitalization equivalent).
Hierarchical occurrence within efficacy assessment time interval (EATI) of:
Time frame: 12 months
Change in KCCQ relative to baseline
Hierarchical occurrence within efficacy assessment time interval (EATI) of:
Time frame: 12 months
MACCE defined as the composite of all-cause death, all stroke, and hospitalizations for heart failure or symptomatic aortic valve disease or clinically significant worsening of heart failure within EATI. Hierarchical occurrence within EATI of:
1. All-cause death 2. Disabling stroke 3. Hospitalizations related to heart failure, symptomatic aortic valve disease or non-disabling stroke or clinically significant worsening of heart failure (heart failure event)
Time frame: 12 month
-All-cause death within EATI
-All-cause death within EATI
Time frame: 12 month
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Chandler Regional Medical Center
Chandler, Arizona, United States
UCSD/Sulpizio Cardiovascular Center
La Jolla, California, United States
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Los Angeles, California, United States
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UCSF
San Francisco, California, United States
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University of Miami
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...and 41 more locations