The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis.
This registry is a subgroup of Asian TAVR registry(NCT02308150) and Asian TAVR registry changes to TP-TAVR registry(NCT03826264). Some subjects moved to TP-TAVR registry and continue to 10-year follow-up.
Study Type
OBSERVATIONAL
Enrollment
102
Asan Medical Center
Seoul, South Korea
Death
Time frame: 1 month
Death
Time frame: 6 months
Death
Time frame: 1 year
Death
Time frame: 2 years
Death
Time frame: 3 years
Death
Time frame: 4 years
Death
Time frame: 5 years
Death from cardiac cause
Time frame: 1 month
Death from cardiac cause
Time frame: 6 months
Death from cardiac cause
Time frame: 1 year
Death from cardiac cause
Time frame: 2 years
Death from cardiac cause
Time frame: 3 years
Death from cardiac cause
Time frame: 4 years
Death from cardiac cause
Time frame: 5 years
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Stroke
Time frame: 1 month
Stroke
Time frame: 6 months
Stroke
Time frame: 1 year
Stroke
Time frame: 2 years
Stroke
Time frame: 3 years
Stroke
Time frame: 4 years
Stroke
Time frame: 5 years
Myocardial infarction
Time frame: 1 month
Myocardial infarction
Time frame: 6 months
Myocardial infarction
Time frame: 1 year
Myocardial infarction
Time frame: 2 years
Myocardial infarction
Time frame: 3 years
Myocardial infarction
Time frame: 4 years
Myocardial infarction
Time frame: 5 years
Repeat hospitalization
Time frame: 1 month
Repeat hospitalization
Time frame: 6 months
Repeat hospitalization
Time frame: 1 year
Repeat hospitalization
Time frame: 2 years
Repeat hospitalization
Time frame: 3 years
Repeat hospitalization
Time frame: 4 years
Repeat hospitalization
Time frame: 5 years
Acute kidney injury
Time frame: 1 month
Acute kidney injury
Time frame: 6 months
Acute kidney injury
Time frame: 1 year
Acute kidney injury
Time frame: 2 years
Acute kidney injury
Time frame: 3 years
Acute kidney injury
Time frame: 4 years
Acute kidney injury
Time frame: 5 years
Vascular complication
Time frame: 1 month
Vascular complication
Time frame: 6 months
Vascular complication
Time frame: 1 year
Vascular complication
Time frame: 2 years
Vascular complication
Time frame: 3 years
Vascular complication
Time frame: 4 years
Vascular complication
Time frame: 5 years
Bleeding events
Time frame: 1 month
Bleeding events
Time frame: 6 months
Bleeding events
Time frame: 1 year
Bleeding events
Time frame: 2 years
Bleeding events
Time frame: 3 years
Bleeding events
Time frame: 4 years
Bleeding events
Time frame: 5 years
Device success
Time frame: 1 month
Device success
Time frame: 6 months
Device success
Time frame: 1 year
Device success
Time frame: 2 years
Device success
Time frame: 3 years
Device success
Time frame: 4 years
Device success
Time frame: 5 years
Early safety as a composite of all cause mortality, all stroke, life threatening bleeding, acute kidney injury, coronary artery obstruction requiring intervention, major vascular complication, valve related dysfunction requiring repeat procedure
Time frame: 1 month
Clinical Efficacy as a composite of all cause mortality, all stroke, hospitalization for valve related symptoms or worsening congestive heart failure, NYHA class III or IV, prosthetic heart valve dysfunction
Time frame: 1 month, 6 months, and annually at 1 to 5 years
Time related valve safety as a composite of structural valve deterioration, prosthetic valve endocarditis, prosthetic valve thrombosis, thromboembolic events, VARC bleeding(unless clearly unrelated to valve therapy)
Time frame: from index procedure to 5 years