RecruitingNot ApplicableNCT06009588
Comparison of Self- and Balloon-expandable Valves in Patients With Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement: The AAD-CHOICE
Sponsor
China National Center for Cardiovascular Diseases
Enrollment
100 participants
Start Date
Aug 31, 2023
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 65 Years
Inclusion Criteria5
- 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 Criteria4
- Dominant aortic regurgitation,;
- A history of SAVR or TAVR;
- A history of aortic surgery;
- Emergent TAVR.
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Interventions
DEVICEself-expandable valves
patients undergoing TAVR use self-expandable valves
DEVICEballoon-expandable valves
patients undergoing TAVR use balloon-expandable valves
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06009588
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