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| Name | Class |
|---|---|
| CardioVascular Research Foundation, Korea | OTHER |
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The purpose of this study is to determine that Transcatheter aortic valve replacement (TAVR) with SAPIEN 3 is superior to traditional surgical aortic valve replacement(SAVR) with bio-prosthesis regarding the rate of all-cause mortality at 1 year in patients with symptomatic severe aortic valve stenosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAVR | Experimental | Transcatheter aortic valve replacement with SAPIEN 3 |
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| SAVR | Active Comparator | Surgical aortic valve replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAPIEN 3 | Device |
| ||
| SAVR |
| Measure | Description | Time Frame |
|---|---|---|
| event rate of all-cause mortality | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| event rate of cardiovascular mortality | 30 days or hospital discharge, whichever is longer | |
| event rate of cardiovascular mortality | 31 days to the 1 year | |
| event rate of myocardial Infarction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suck-jung Choo, MD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | Songpa-gu | 138-736 | South Korea |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 30 days or hospital discharge, whichever is longer |
| event rate of myocardial Infarction | 31 days to the 1 year |
| event rate of all Stroke and transient ischemic attack | 30 days or hospital discharge, whichever is longer |
| event rate of all Stroke and transient ischemic attack | 31 days to the 1 year |
| event rate of bleeding | 30 days or hospital discharge, whichever is longer |
| event rate of bleeding | 31 days to the 1 year |
| event rate of vascular access site and access-related complication | 30 days or hospital discharge, whichever is longer |
| event rate of vascular access site and access-related complication | 31 days to the 1 year |
| event rate of acute kidney injury | 30 days or hospital discharge, whichever is longer |
| event rate of acute kidney injury | 31 days to the 1 year |
| event rate of permanent pacemaker insertion | 30 days or hospital discharge, whichever is longer |
| event rate of permanent pacemaker insertion | 31 days to the 1 year |
| event rate of other TAVR-related complication | Conversion to open surgery Coronary obstruction Mitral valve apparatus damage or dysfunction Cardiac tamponade Endocarditis Valve thrombosis Valve malpositioning TAV-in-TAV deployment | 30 days or hospital discharge, whichever is longer |
| event rate of other TAVR-related complication | Conversion to open surgery Coronary obstruction Mitral valve apparatus damage or dysfunction Cardiac tamponade Endocarditis Valve thrombosis Valve malpositioning TAV-in-TAV deployment | 31 days to the 1 year |
| event rate of prosthetic valve dysfunction | Prosthetic aortic valve stenosis Prosthesis-patient mismatch Prosthetic aortic valve regurgitation | 30 days or hospital discharge, whichever is longer |
| event rate of prosthetic valve dysfunction | Prosthetic aortic valve stenosis Prosthesis-patient mismatch Prosthetic aortic valve regurgitation | 31 days to the 1 year |
| event rate of composite event for device success, early safety, clinical efficacy | Number of cases with following events ; A. Device success or B. Early safety (At 30 days): All-cause mortality, all stroke, life threatening bleeding, acute kidney injury, coronary obstruction requiring intervention, major vascular complication, valve-related dysfunction requiring repeat procedure. or C. Clinical efficacy (After 30 days): All-cause mortality, all stroke, requiring hospitalization for valve-related symptoms or worsening congestive heart failure, NYHA class III or IV, valve related dysfunction. | 30 days or hospital discharge, whichever is longer |
| event rate of composite event for device success, early safety, clinical efficacy | Number of cases with following events ; A. Device success or B. Early safety (At 30 days): All-cause mortality, all stroke, life threatening bleeding, acute kidney injury, coronary obstruction requiring intervention, major vascular complication, valve-related dysfunction requiring repeat procedure. or C. Clinical efficacy (After 30 days): All-cause mortality, all stroke, requiring hospitalization for valve-related symptoms or worsening congestive heart failure, NYHA class III or IV, valve related dysfunction. | 31 days to the 1 year |
| event rate of structural valve deterioration | 30 days or hospital discharge, whichever is longer |
| event rate of structural valve deterioration | 31 days to the 1 year |
| NYHA (New York Heart Association Functional Classification) | 30days and 1 year |
| Valve area | Aortic valve area (AVA) measured by 2D-transthoracic echocardiography using the continuity equation. | 30days and 1 year |
| event rate of free from atrial fibrillation | 30days and 1 year |
| D014694 |
| Ventricular Outflow Obstruction |