The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis.

Detailed Description
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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.

Official Title
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Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Replacement for Patients With Bicuspid Aortic Valve Stenosis

Conditions
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Aortic Valve Stenosis, Cardiovascular Diseases, Heart Valve Diseases, Bicuspid

Intervention / Treatment
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* Procedure: transcatheter aortic valve replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with bicuspid aortic valve stenosis who are not candidates for surgical aortic valve replacement because of coexisting illnesses. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with bicuspid aortic valve stenosis<br> | Procedure: transcatheter aortic valve replacement<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | 1 month | 
| Death |  | 6 months | 
| Death |  | 1 year | 
| Death |  | 2 years | 
| Death |  | 3 years | 
| Death |  | 4 years | 
| Death |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death from cardiac cause |  | 1 month | 
| Death from cardiac cause |  | 6 months | 
| Death from cardiac cause |  | 1 year | 
| Death from cardiac cause |  | 2 years | 
| Death from cardiac cause |  | 3 years | 
| Death from cardiac cause |  | 4 years | 
| Death from cardiac cause |  | 5 years | 
| Stroke |  | 1 month | 
| Stroke |  | 6 months | 
| Stroke |  | 1 year | 
| Stroke |  | 2 years | 
| Stroke |  | 3 years | 
| Stroke |  | 4 years | 
| Stroke |  | 5 years | 
| Myocardial infarction |  | 1 month | 
| Myocardial infarction |  | 6 months | 
| Myocardial infarction |  | 1 year | 
| Myocardial infarction |  | 2 years | 
| Myocardial infarction |  | 3 years | 
| Myocardial infarction |  | 4 years | 
| Myocardial infarction |  | 5 years | 
| Repeat hospitalization |  | 1 month | 
| Repeat hospitalization |  | 6 months | 
| Repeat hospitalization |  | 1 year | 
| Repeat hospitalization |  | 2 years | 
| Repeat hospitalization |  | 3 years | 
| Repeat hospitalization |  | 4 years | 
| Repeat hospitalization |  | 5 years | 
| Acute kidney injury |  | 1 month | 
| Acute kidney injury |  | 6 months | 
| Acute kidney injury |  | 1 year | 
| Acute kidney injury |  | 2 years | 
| Acute kidney injury |  | 3 years | 
| Acute kidney injury |  | 4 years | 
| Acute kidney injury |  | 5 years | 
| Vascular complication |  | 1 month | 
| Vascular complication |  | 6 months | 
| Vascular complication |  | 1 year | 
| Vascular complication |  | 2 years | 
| Vascular complication |  | 3 years | 
| Vascular complication |  | 4 years | 
| Vascular complication |  | 5 years | 
| Bleeding events |  | 1 month | 
| Bleeding events |  | 6 months | 
| Bleeding events |  | 1 year | 
| Bleeding events |  | 2 years | 
| Bleeding events |  | 3 years | 
| Bleeding events |  | 4 years | 
| Bleeding events |  | 5 years | 
| Device success |  | 1 month | 
| Device success |  | 6 months | 
| Device success |  | 1 year | 
| Device success |  | 2 years | 
| Device success |  | 3 years | 
| Device success |  | 4 years | 
| Device success |  | 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 |  | 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 |  | 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) |  | from index procedure to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcatheter aortic valve replacement