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

NCT ID: NCT02838199

Last Updated: 2016-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2030-12-31

Brief Summary

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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

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Conditions

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Aortic Valve Stenosis

Keywords

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Transcatheter aortic valve replacement TAVR TAVI SAVR

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

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SAPIEN 3

Intervention Type DEVICE

SAVR

Intervention Type PROCEDURE

Eligibility Criteria

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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

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CardioVascular Research Foundation, Korea

OTHER

Sponsor Role collaborator

Seung-Jung Park

OTHER

Sponsor Role lead

Responsible Party

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Seung-Jung Park

professor of medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Suck-jung Choo, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, Songpa-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AMCCV2016-16

Identifier Type: -

Identifier Source: org_study_id