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Comparison of Self- and Balloon-expandable Valves in Patients With Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement: The AAD-CHOICE

Comparison of Self- and Balloon-expandable Valves in Patients With Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement: The AAD-CHOICE

Recruiting
65 years and older
All
Phase N/A

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Overview

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.

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 replacement (SAVR), current guidelines recommend concomitant aortic repair or replacement if the diameter of AA exceeds 45mm to avoid aortic dissection or rupture.

Transcatheter aortic valve replacement (TAVR) has profoundly changed the clinical management of AS patients who cannot tolerate SAVR. For patients who are candidates for TAVR, simultaneous repair of a dilated AA can be technically difficult. The safety and feasibility of the procedure and the fate of AA after the procedure in these patients remain unclear. Moreover, there are limited data comparing the performance of self-expandable valves versus balloon-expandable valves in these patients. The aim of the present study is to evaluate the impact of type of transcatheter heart valves on intra-procedural device success and post-procedural AA progression in patients with dilated AA (≥45mm) undergoing TAVR.

Eligibility

Inclusion Criteria:

  • 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 Criteria:

  • Dominant aortic regurgitation,;
  • A history of SAVR or TAVR;
  • A history of aortic surgery;
  • Emergent TAVR.

Study details
    Aortic Stenosis
    Ascending Aortic Dilatation

NCT06009588

China National Center for Cardiovascular Diseases

15 October 2025

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