Transpacific TAVR Registry

Study Overview
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Brief Summary
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This registry evaluates the long-term outcome of Transcatheter aortic valve replacement (TAVR) in real-world clinical practice.

Detailed Description
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This study is connected with Asian TAVR registry(NCT02308150). Some subjects from Asian TAVR registry continue 10 years follow-up on this TP-TAVR registry.

Official Title
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a Multinational Multicenter Prospective Transpacific TAVR Registry

Conditions
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Heart Valve Diseases, Aortic Valve Insufficiency

Intervention / Treatment
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* Procedure: TAVR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients undergoing TAVR Informed consent

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Korea Centers<br>Seoul, Korea All Patients undergoing TAVR | Procedure: TAVR<br>* transcatheter aortic valve replacement (TAVR)<br>|
| Stanford University<br>California, USA All Patients undergoing TAVR | Procedure: TAVR<br>* transcatheter aortic valve replacement (TAVR)<br>|
| Northwestern University<br>Evanston, Illinois, USA All Patients undergoing TAVR | Procedure: TAVR<br>* transcatheter aortic valve replacement (TAVR)<br>|
| Cheng-Hsin Hospital<br>Taipei, Taiwan All Patients undergoing TAVR | Procedure: TAVR<br>* transcatheter aortic valve replacement (TAVR)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event rate of all cause death |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event rate of cardiovascular death | A. Death due to proximate cardiac cause B. Death caused by non-coronary vascular condition C. All procedure-related death D. All valve-related death E. Sudden or unwitnessed death F. Death of unknown cause | 10 years | 
| Event rate of myocardial infarction | according to Valve Academic Research Consortium (VARC) criteria | 10 years | 
| Event rate of cerebrovascular accident | stroke and TIA (Transient Ischemic Attack) | 10 years | 
| Event rate of bleeding | according to Valve Academic Research Consortium (VARC) criteria | 10 years | 
| Event rate of Vascular access site and access-related complication | according to Valve Academic Research Consortium (VARC) criteria | 30 days | 
| Event rate of Acute kidney injury |  | 30 days | 
| Event rate of Permanent pacemaker insertion |  | 10 years | 
| Event rate of Other TAVR-related complication | A. Conversion to open surgery B. Coronary obstruction C. Mitral valve apparatus damage or dysfunction D. Cardiac tamponade E. Endocarditis F. Valve thrombosis G. Valve mal-positioning H. TAV-in-TAV deployment | 10 years | 
| Event rate of Prosthetic valve dysfunction | according to Valve Academic Research Consortium (VARC) criteria A. Prosthetic aortic valve stenosis B. Prosthesis-patient mismatch C. Prosthetic aortic valve regurgitation | 10 years | 
| Event rate of Composite endpoint | A. Device success B. Early safety : death, cerebrovascular event, fatal bleeding, acute kidney injury, coronary obstruction requiring intervention, major vascular complication, valve dysfunction requiring intervention C. Clinical efficacy : death, cerebrovascular event, valve-related symptom requiring hospitalization or devastating heart failure, NYHA class* III, IV dyspnea, valve dysfunction *the New York Heart Association (NYHA) Functional Classification | 10 years | 
| Event rate of Structural valve deterioration |  | 10 years | 
| NYHA class |  | 30 days | 
| NYHA class |  | 1 year | 
| Valve area |  | 1 year | 
| Event rate of free from atrial fibrillation |  | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVR, TAVI, real-world