TRANscatheter or SurgIcal Aortic Valve ReplacemenT in All-Comers With Severe Aortic Valve Stenosis

Seung-Jung Park

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Aortic Valve Stenosis

Interventions

SAPIEN 3DEVICE

SAVRPROCEDURE

Eligibility

Sex: ALLMin age: 19 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Asan Medical Center

Seoul, Songpa-gu, South Korea

Outcomes

Primary Outcomes

event rate of all-cause mortality

Time frame: 1 year