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

Seung-Jung Park

Status and phase

Withdrawn

Phase 4

Conditions

Aortic Valve Stenosis

Treatments

Procedure: SAVR

Device: SAPIEN 3

Study type

Interventional

Funder types

Other

Identifiers

NCT02838199

AMCCV2016-16

Details and patient eligibility

About

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.

Sex

All

Ages

19 to 75 years old

Volunteers

No Healthy Volunteers

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.