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

Phase 4

Withdrawn

• Conditions: Aortic Valve Stenosis
• Interventions: Procedure: SAVR; Device: SAPIEN 3

• Registration Number: NCT02838199
• Lead Sponsor: Seung-Jung Park

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-06
• Study First Submitted QC: 2016-07-17
• Study First Posted: 2016-07-20
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-22
• Last Update Posted: 2016-11-25
• Study Start: 2016-12
• Primary Completion: 2020-06
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SAVR	SAVR	Surgical aortic valve replacement
TAVR	SAPIEN 3	Transcatheter aortic valve replacement with SAPIEN 3

Primary Outcome Measures

Name	Time	Method
event rate of all-cause mortality	1 year

Secondary Outcome Measures

Name	Time	Method
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	Conversion to open surgery Coronary obstruction Mitral valve apparatus damage or dysfunction Cardiac tamponade Endocarditis Valve thrombosis Valve malpositioning TAV-in-TAV deployment
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	Prosthetic aortic valve stenosis Prosthesis-patient mismatch Prosthetic aortic valve regurgitation
event rate of composite event for device success, early safety, clinical efficacy	31 days to the 1 year	Number of cases with following events ; A. Device success; or; B. Early safety (At 30 days): All-cause mortality, all stroke, life threatening bleeding, acute kidney injury, coronary obstruction requiring intervention, major vascular complication, valve-related dysfunction requiring repeat procedure.; or; C. Clinical efficacy (After 30 days): All-cause mortality, all stroke, requiring hospitalization for valve-related symptoms or worsening congestive heart failure, NYHA class III or IV, valve related dysfunction.
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	Aortic valve area (AVA) measured by 2D-transthoracic echocardiography using the continuity equation.

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Songpa-gu, Korea, Republic of