Status:
RECRUITING
Comparison of Self- and Balloon-expandable Valves in Patients With Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement: The AAD-CHOICE
Lead Sponsor:
China National Center for Cardiovascular Diseases
Conditions:
Aortic Stenosis
Ascending Aortic Dilatation
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
This study aimed at comparing the performance of self-expandable valves versus balloon-expandable valves in patients with ascending aortic dilation undergoing transcatheter aortic valve replacement.
Detailed Description
Ascending aortic (AA) dilation is a common feature in patients with aortic stenosis (AS), especially in those with bicuspid aortic valve (BAV). For patients undergoing surgical aortic valve replacemen...
Eligibility Criteria
Inclusion
- Severe aortic stenosis;
- Transfemoral access;
- Preoperative aortic CT suggesting maximum ascending aortic diameter ≥45mm and \<55mm;
- Anticipated life expectancy \>1 year;
- Age ≥ 65 years.
Exclusion
- Dominant aortic regurgitation,;
- A history of SAVR or TAVR;
- A history of aortic surgery;
- Emergent TAVR.
Key Trial Info
Start Date :
August 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06009588
Start Date
August 31 2023
End Date
August 30 2026
Last Update
August 5 2024
Active Locations (1)
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1
National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, China, 100037