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| Name | Class |
|---|---|
| CardioVascular Research Foundation, Korea | OTHER |
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This study evaluated effectiveness and safety of aortic valve replacement in real-world clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAVR | Transcatheter Aortic Valve Replacement |
| |
| Sutureless AVR | Sutureless Aortic Valve Replacement |
| |
| Conventional AVR | Conventional Aortic Valve Replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valve Replacement | Procedure | Aortic valve replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause death | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular mortality | A. Death due to proximate cardiac cause B. Death caused by noncoronary vascular condition C. All procedure-related/surgery-related death D. All valve-related death E. Sudden or unwitnessed death F. Death of unknown cause Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with aortic valve replacement
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| Name | Affiliation | Role |
|---|---|---|
| Suk-Jung Choo, MD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sejong Hospital | Bucheon-si | South Korea | ||||
| Asan Medical Center |
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| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Myocardial infarction | Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years | 5 years |
| All stroke and transient ischemic attack | Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years | 5 years |
| Bleeding | Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years | 5 years |
| Access site complication | Operation site complication Vascular access site and access-related complication Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years | 5 years |
| Acute kidney injury | Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years | 5 years |
| Permanent pacemaker insertion | Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years | 5 years |
| 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 malpositioning H. TAV-in-TAV deployment Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years | 5 years |
| Prosthetic valve dysfunction | A. Prosthetic aortic valve stenosis B. Prosthesis-patient mismatch C. Prosthetic aortic valve regurgitation Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years | 5 years |
| Composite event | A. Device success B. Early safety (30 days)
Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years | 5 years |
| Structural valve deterioration | Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years | 5 years |
| NYHA class | New York Heart Association (NYHA) Functional Classification | 30 days and 1 year |
| The change of valve area | Aortic valve area measured by echocardiography (mm2) | 30 days and 1 year |
| New onset atrial fibrillation | 30 days and 1 year |
| Seoul |
| South Korea |
| Pusan National University Yangsan Hospital | Yangsan | South Korea |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |