Aortic Valve Disease, Aortic Valve Stenosis
Conditions
Keywords
TAVR, SAVR, TAVI, Conventional AVR, Sutureless AVR
Brief summary
This study evaluated effectiveness and safety of aortic valve replacement in real-world clinical practice.
Interventions
PROCEDUREValve Replacement
Aortic valve replacement
Sponsors
CardioVascular Research Foundation, Korea
Seung-Jung Park
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 19 and more * Patient with aortic valve replacement
Exclusion criteria
* Combined with mitral stenosis requiring surgery or aorta stenosis * Acute bacterial endocarditis within 1 month of valve replacement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause death | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial infarction | 5 years | Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years |
| All stroke and transient ischemic attack | 5 years | Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years |
| Bleeding | 5 years | Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years |
| Access site complication | 5 years | 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 |
| Acute kidney injury | 5 years | Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years |
| Permanent pacemaker insertion | 5 years | Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years |
| Cardiovascular mortality | 5 years | 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 |
| Prosthetic valve dysfunction | 5 years | 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 |
| Composite event | 5 years | A. Device success B. Early safety (30 days) * Death, stroke, life-threatening bleeding, acute kidney injury, coronary stenosis requiring intervention, significant vascular complication, valve dysfunction requiring intervention C. Clinical efficacy (30 days) * Death, stroke, deteriorating heart failure or valve function requiring hospitalization, NYHA III or IV dyspnea, valve dysfunction Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years |
| Structural valve deterioration | 5 years | Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years |
| NYHA class | 30 days and 1 year | New York Heart Association (NYHA) Functional Classification |
| The change of valve area | 30 days and 1 year | Aortic valve area measured by echocardiography (mm2) |
| New onset atrial fibrillation | 30 days and 1 year | — |
| TAVR-related complication | 5 years | 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 |
Countries
South Korea
Outcome results
None listed