Clinical trial NCT02838199: TRANscatheter or SurgIcal Aortic Valve ReplacemenT in All-Comers With Severe Aortic Valve Stenosis
Official title: Prospective, Open Label, Multicenter, Dual Arm, Randomized Trial of TRANscatheter or SurgIcal Aortic Valve ReplacemenT in All-Comers With Severe Aortic Valve Stenosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Aortic Valve Stenosis
Keywords: Transcatheter aortic valve replacement
TAVR
TAVI
SAVR
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2016-07-20
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 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.

Primary outcomes:
measure: event rate of all-cause mortality
timeFrame: 1 year
Secondary outcomes:
measure: event rate of cardiovascular mortality
timeFrame: 30 days or hospital discharge, whichever is longer
measure: event rate of cardiovascular mortality
timeFrame: 31 days to the 1 year
measure: event rate of myocardial Infarction
timeFrame: 30 days or hospital discharge, whichever is longer
measure: event rate of myocardial Infarction
timeFrame: 31 days to the 1 year
measure: event rate of all Stroke and transient ischemic attack
timeFrame: 30 days or hospital discharge, whichever is longer
measure: event rate of all Stroke and transient ischemic attack
timeFrame: 31 days to the 1 year
measure: event rate of bleeding
timeFrame: 30 days or hospital discharge, whichever is longer
measure: event rate of bleeding
timeFrame: 31 days to the 1 year
measure: event rate of vascular access site and access-related complication
timeFrame: 30 days or hospital discharge, whichever is longer
measure: event rate of vascular access site and access-related complication
timeFrame: 31 days to the 1 year
measure: event rate of acute kidney injury
timeFrame: 30 days or hospital discharge, whichever is longer
measure: event rate of acute kidney injury
timeFrame: 31 days to the 1 year
measure: event rate of permanent pacemaker insertion
timeFrame: 30 days or hospital discharge, whichever is longer
measure: event rate of permanent pacemaker insertion
timeFrame: 31 days to the 1 year
measure: event rate of other TAVR-related complication
timeFrame: 30 days or hospital discharge, whichever is longer
measure: event rate of other TAVR-related complication
timeFrame: 31 days to the 1 year
measure: event rate of prosthetic valve dysfunction
timeFrame: 30 days or hospital discharge, whichever is longer
measure: event rate of prosthetic valve dysfunction
timeFrame: 31 days to the 1 year
measure: event rate of composite event for device success, early safety, clinical efficacy
timeFrame: 30 days or hospital discharge, whichever is longer
measure: event rate of composite event for device success, early safety, clinical efficacy
timeFrame: 31 days to the 1 year
measure: event rate of structural valve deterioration
timeFrame: 30 days or hospital discharge, whichever is longer
measure: event rate of structural valve deterioration
timeFrame: 31 days to the 1 year
measure: NYHA (New York Heart Association Functional Classification)
timeFrame: 30days and 1 year
measure: Valve area
timeFrame: 30days and 1 year
measure: event rate of free from atrial fibrillation
timeFrame: 30days and 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
Study officials:
affiliation: Asan Medical Center
name: Suck-jung Choo, MD
role: PRINCIPAL_INVESTIGATOR
References: