The Safety and Effectiveness of Transcatheter Aortic Valve Raplacemet in Intermediate Risk Patients With Bicuspid Aortic Stenosis
NCT ID: NCT03163329
Last Updated: 2018-01-11
Study Results
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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UNKNOWN
PHASE2
300 participants
INTERVENTIONAL
2018-02-01
2024-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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TAVR group
TAVR
Transcatheter Aortic Valve Replacement
SAVR group
SAVR
Surgical Aortic Valve Replacement
Interventions
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TAVR
Transcatheter Aortic Valve Replacement
SAVR
Surgical Aortic Valve Replacement
Eligibility Criteria
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Inclusion Criteria
2. Heart team agrees the patient has a risk of operative mortality and has an STS \<8 and \>3.
3. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
Exclusion Criteria
2. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.
3. Severe aortic regurgitation (\>3+).
4. Severe mitral regurgitation (\>3+).
18 Years
ALL
No
Sponsors
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China National Center for Cardiovascular Diseases
OTHER_GOV
Responsible Party
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Yongjian Wu
Clinical Professor
Central Contacts
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Other Identifiers
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AS-20170520
Identifier Type: -
Identifier Source: org_study_id
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