TRANscatheter or SurgIcal Aortic Valve ReplacemenT in All-Comers With Severe Aortic Valve Stenosis (NCT02838199) | Clinical Trial Compass
WithdrawnPhase 4
TRANscatheter or SurgIcal Aortic Valve ReplacemenT in All-Comers With Severe Aortic Valve Stenosis
South Korea0Started 2016-12
Plain-language 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.
Who can participate
Age range19 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…