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

NCT ID: NCT02838199

Last Updated: 2016-11-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2030-12-31

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.

Conditions

Aortic Valve Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAVR

Transcatheter aortic valve replacement with SAPIEN 3

Group Type: EXPERIMENTAL

SAPIEN 3

Intervention Type: DEVICE

SAVR

Surgical aortic valve replacement

Group Type: ACTIVE_COMPARATOR

SAVR

Intervention Type: PROCEDURE

Interventions

SAPIEN 3

Intervention Type: DEVICE

SAVR

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CardioVascular Research Foundation, Korea

OTHER

Sponsor Role: collaborator

Seung-Jung Park

OTHER

Sponsor Role: lead

Responsible Party

Seung-Jung Park

professor of medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Suck-jung Choo, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, Songpa-gu, South Korea

Countries

South Korea

Other Identifiers

AMCCV2016-16

Identifier Type: -

Identifier Source: org_study_id