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)

National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, China

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NCT06009588


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