Aortic Valve Stenosis
Conditions
Keywords
Transcatheter aortic valve replacement, TAVR, TAVI, SAVR
Brief summary
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.
Sponsors
CardioVascular Research Foundation, Korea
Seung-Jung Park
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age must be at least 19 and less than 75 years old * Severe aortic valve stenosis with echocardiographically derived criteria: mean gradient \> 40mmHg or jet velocity greater than 4.0 m/s AND an initial aortic valve area (AVA) of ≤ 0.8 cm2. Echocardiogram must be within 3 months of the date of the procedure * Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA class II or greater. * The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Exclusion criteria
* Life expectancy \<1 year due to medical illness * Suspected Malignancy * Inoperability evaluated by surgeon * Concomitant severe coronary artery disease not amenable for percutaneous coronary intervention * Concomitant severe mitral valve or significant aorta disease requiring surgery * Active bacterial endocarditis within 6 months of procedure * Leukopenia (WBC\<3000 cell/mL), acute anemia (Hgb\<8g/dL), thrombocytopenia (platelet \< 50000 cell/mL) * Intracardiac thrombus * A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure. * Native aortic annulus size \< 18 mm or \> 25 mm as measured by echocardiogram. * Expectation that patient will not improve despite treatment of aortic stenosis * Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| event rate of all-cause mortality | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| event rate of myocardial Infarction | 30 days or hospital discharge, whichever is longer | — |
| event rate of all Stroke and transient ischemic attack | 30 days or hospital discharge, whichever is longer | — |
| event rate of bleeding | 30 days or hospital discharge, whichever is longer | — |
| event rate of vascular access site and access-related complication | 30 days or hospital discharge, whichever is longer | — |
| event rate of acute kidney injury | 30 days or hospital discharge, whichever is longer | — |
| event rate of permanent pacemaker insertion | 30 days or hospital discharge, whichever is longer | — |
| event rate of cardiovascular mortality | 30 days or hospital discharge, whichever is longer | — |
| event rate of prosthetic valve dysfunction | 30 days or hospital discharge, whichever is longer | Prosthetic aortic valve stenosis Prosthesis-patient mismatch Prosthetic aortic valve regurgitation |
| event rate of composite event for device success, early safety, clinical efficacy | 30 days or hospital discharge, whichever is longer | 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. |
| event rate of structural valve deterioration | 30 days or hospital discharge, whichever is longer | — |
| NYHA (New York Heart Association Functional Classification) | 30days and 1 year | — |
| Valve area | 30days and 1 year | Aortic valve area (AVA) measured by 2D-transthoracic echocardiography using the continuity equation. |
| event rate of free from atrial fibrillation | 30days and 1 year | — |
| event rate of other TAVR-related complication | 30 days or hospital discharge, whichever is longer | Conversion to open surgery Coronary obstruction Mitral valve apparatus damage or dysfunction Cardiac tamponade Endocarditis Valve thrombosis Valve malpositioning TAV-in-TAV deployment |
Countries
South Korea
Outcome results
None listed