The Asian Pacific TAVR Multicenter 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 the Asian Pacific population

Official Title
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Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Replacement in the Asian Population The Asian Pacific TAVI Multicenter Registry A MULTICENTER, OBSERVATIONAL STUDY

Conditions
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Aortic Valve Stenosis

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: Patients with symptomatic severe aortic 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 |
| --- | --- |
| transcatheter aortic valve Replacement<br>Patients with symptomatic severe aortic stenosis who are not candidates for surgical aortic valve replacement because of coexisting illnesses. | Device: 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 from any cause |  | 1 month | 
| Death from any cause |  | 6 months | 
| Death from any cause |  | 1 year | 
| Death from any cause |  | 2 years | 
| Death from any cause |  | 3 years | 
| Death from any cause |  | 4 years | 
| Death from any cause |  | 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 | Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation) | 1 month | 
| Device success | Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation) | 6 months | 
| Device success | Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation) | 1 year | 
| Device success | Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation) | 2 years | 
| Device success | Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation) | 3 years | 
| Device success | Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation) | 4 years | 
| Device success | Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation) | 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