Back to resultsThe Safety and Effectiveness of Transcatheter Aortic Valve Raplacemet in Intermediate Risk Patients With Bicuspid Aortic Stenosis
Primary Purpose
Aortic Valve Disease
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
TAVR
SAVR
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Valve Disease
Eligibility Criteria
Inclusion Criteria:
- Severe, calcific bicuspid aortic stenosis.
- Heart team agrees the patient has a risk of operative mortality and has an STS <8 and >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:
- Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath.
- Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.
- Severe aortic regurgitation (>3+).
- Severe mitral regurgitation (>3+).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TAVR group
SAVR group
Arm Description
Outcomes
Primary Outcome Measures
All-cause mortality, all stroke, and re-hospitalization
This composite endpoint will be evaluated as a non-inferiority analysis based on a relative non-inferiority margin of 35%
Secondary Outcome Measures
Full Information
NCT ID
NCT03163329
First Posted
May 20, 2017
Last Updated
January 10, 2018
Sponsor
China National Center for Cardiovascular Diseases
1. Study Identification
Unique Protocol Identification Number
NCT03163329
Brief Title
The Safety and Effectiveness of Transcatheter Aortic Valve Raplacemet in Intermediate Risk Patients With Bicuspid Aortic Stenosis
Official Title
A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of Transcatheter Aortic Valve Raplacemet in Intermediate Risk Patients Who Have Severe, Calcific, Bicuspid, Aortic Stenosis Requiring Aortic Valve Replacement
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2018 (Anticipated)
Primary Completion Date
October 31, 2020 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China National Center for Cardiovascular Diseases
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Previous trials have shown that TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk. However, patients with congenital bicuspid valve have been excluded in those trials. The purpose of this trial is to determine the safety and effectiveness of TAVR in intermediate-risk patients with bicuspid aortic valve stenosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TAVR group
Arm Type
Experimental
Arm Title
SAVR group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
TAVR
Intervention Description
Transcatheter Aortic Valve Replacement
Intervention Type
Procedure
Intervention Name(s)
SAVR
Intervention Description
Surgical Aortic Valve Replacement
Primary Outcome Measure Information:
Title
All-cause mortality, all stroke, and re-hospitalization
Description
This composite endpoint will be evaluated as a non-inferiority analysis based on a relative non-inferiority margin of 35%
Time Frame
1 year post procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Severe, calcific bicuspid aortic stenosis.
Heart team agrees the patient has a risk of operative mortality and has an STS <8 and >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:
Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath.
Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.
Severe aortic regurgitation (>3+).
Severe mitral regurgitation (>3+).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong-jian Wu, M.D, Ph.D
Phone
0086-10-88396780
Email
fuwaihospital@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
The Safety and Effectiveness of Transcatheter Aortic Valve Raplacemet in Intermediate Risk Patients With Bicuspid Aortic Stenosis
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