Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry

Study Overview
=================
Brief Summary
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The objective of this study is to evaluate the procedural and clinical outcomes of patients with bicuspid aortic valve stenosis undergoing transcatheter aortic valve replacement.

Official Title
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The International Multicenter Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry

Conditions
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Bicuspid Aortic Valve

Intervention / Treatment
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* Device: Transcatheter aortic valve replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≥18 years. Severe aortic stenosis with bicuspid anatomy. NYHA≥2 and/or syncope and/or angina. Patient judged by the Heart Team as indicated for TAVR. Exclusion Criteria: Age <18 years Asymptomatic patients Pure aortic regurgitation.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 129 Years

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

| Intervention/Treatment |
| --- |
|Device: Transcatheter aortic valve replacement|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | Death from any cause | 1 month | 
| Death | Death from any cause | 1 year | 
| Death | Death from any cause | 2 years | 
| Death | Death from any cause | 3 years | 
| Death | Death from any cause | 4 years | 
| Death | Death from any cause | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death from cardiac cause | Death from cardiac cause | 1 month | 
| Death from cardiac cause | Death from cardiac cause | 1 year | 
| Death from cardiac cause | Death from cardiac cause | 2 years | 
| Death from cardiac cause | Death from cardiac cause | 3 years | 
| Death from cardiac cause | Death from cardiac cause | 4 years | 
| Death from cardiac cause | Death from cardiac cause | 5 years | 
| Stroke | disabling and non-disabling stroke | 1 month | 
| Stroke | disabling and non-disabling stroke | 1 year | 
| Stroke | disabling and non-disabling stroke | 2 years | 
| Stroke | disabling and non-disabling stroke | 3 years | 
| Stroke | disabling and non-disabling stroke | 4 years | 
| Stroke | disabling and non-disabling stroke | 5 years | 
| Repeat hospitalization | Number of hospitalizations | 1 month | 
| Repeat hospitalization | Number of hospitalizations | 1 year | 
| Repeat hospitalization | Number of hospitalizations | 2 years | 
| Repeat hospitalization | Number of hospitalizations | 3 years | 
| Repeat hospitalization | Number of hospitalizations | 4 years | 
| Repeat hospitalization | Number of hospitalizations | 5 years | 
| Bleeding | Life-threatening or major bleeding rate | 1 month | 
| Bleeding | Life-threatening or major bleeding rate | 1 year | 
| Bleeding | Life-threatening or major bleeding rate | 2 years | 
| Bleeding | Life-threatening or major bleeding rate | 3 years | 
| Bleeding | Life-threatening or major bleeding rate | 4 years | 
| Bleeding | Life-threatening or major bleeding rate | 5 years | 
| Vascular complication | Major vascular complication | 1 month | 
| Vascular complication | Major vascular complication | 1 year | 
| Vascular complication | Major vascular complication | 2 years | 
| Vascular complication | Major vascular complication | 3 years | 
| Vascular complication | Major vascular complication | 4 years | 
| Vascular complication | Major vascular complication | 5 years | 
| Acute kidney injury (stage 2 or 3) |  | 1 month | 
| Acute kidney injury (stage 2 or 3) |  | 1 year | 
| Acute kidney injury (stage 2 or 3) |  | 2 years | 
| Acute kidney injury (stage 2 or 3) |  | 3 years | 
| Acute kidney injury (stage 2 or 3) |  | 4 years | 
| Acute kidney injury (stage 2 or 3) |  | 5 years | 
| Prosthetic regurgitation by Doppler echocardiography |  | at discharge | 
| Prosthetic regurgitation by Doppler echocardiography |  | 1 month | 
| Prosthetic regurgitation by Doppler echocardiography |  | 1 year | 
| Prosthetic regurgitation by Doppler echocardiography |  | 2 years | 
| Prosthetic regurgitation by Doppler echocardiography |  | 3 years | 
| Prosthetic regurgitation by Doppler echocardiography |  | 4 years | 
| Prosthetic regurgitation by Doppler echocardiography |  | 5 years | 
| Mean aortic valve gradient by Doppler echocardiography |  | 1 month | 
| Mean aortic valve gradient by Doppler echocardiography |  | 1 year | 
| Mean aortic valve gradient by Doppler echocardiography |  | 2 years | 
| Mean aortic valve gradient by Doppler echocardiography |  | 3 years | 
| Mean aortic valve gradient by Doppler echocardiography |  | 4 years | 
| Mean aortic valve gradient by Doppler echocardiography |  | 5 years |