Prospective, Open Label, Multicenter, Dual Arm, Randomized Trial of TRANscatheter or SurgIcal Aortic Valve ReplacemenT in All-Comers With Severe Aortic Valve Stenosis

Seung-Jung Park1 site in 1 countryDecember 2016

ConditionsAortic Valve Stenosis

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Aortic Valve Stenosis
Sponsor: Seung-Jung Park
Locations: 1
Primary Endpoint: event rate of all-cause mortality
Status: Withdrawn
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2016

End Date

December 2030

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seung-Jung Park

Responsible Party

Sponsor Investigator

Principal Investigator

Seung-Jung Park

professor of medicine

Asan Medical Center

Eligibility Criteria

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 cm
•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.

Outcomes

Primary Outcomes

event rate of all-cause mortality

Time Frame: 1 year

Secondary Outcomes

event rate of myocardial Infarction(31 days to the 1 year)
event rate of acute kidney injury(31 days to the 1 year)
event rate of other TAVR-related complication(31 days to the 1 year)
event rate of free from atrial fibrillation(30days and 1 year)
event rate of bleeding(31 days to the 1 year)
event rate of vascular access site and access-related complication(31 days to the 1 year)
event rate of prosthetic valve dysfunction(31 days to the 1 year)
event rate of composite event for device success, early safety, clinical efficacy(31 days to the 1 year)
event rate of cardiovascular mortality(31 days to the 1 year)
event rate of all Stroke and transient ischemic attack(31 days to the 1 year)
event rate of structural valve deterioration(31 days to the 1 year)
NYHA (New York Heart Association Functional Classification)(30days and 1 year)
event rate of permanent pacemaker insertion(31 days to the 1 year)
Valve area(30days and 1 year)