Protocol for a randomized controlled trial for comparison of self- and balloon-expandable valves in patients with Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement (AAD-CHOICE).

BACKGROUND

Self-expandable valves (SEVs) and balloon-expandable valves (BEVs) are the most widely used transcatheter heart valves. In patients with ascending aortic dilation (AAD) who undergo transcatheter aortic valve replacement (TAVR), comparison of two type of valves is lacking.

METHODS

The AAD-CHOICE trial is a multi-center, randomized controlled, open-label study. The trial will randomly assign 100 patients with AAD (ascending aortic diameter ≥ 45 mm) who undergo TAVR in 1:1 ratio to either SEV group or BEV group. Participants will be followed for a minimum of 1 year. The primary end point is device success, 30-day all-cause mortality and 30-day adverse aortic events. The key secondary end point is 1-year all-cause mortality, 1-year cardiovascular mortality, adverse aortic events, major adverse cardiovascular and cerebrovascular events, and aortic expansion rate ≥ 3 mm/year.

DISCUSSION: The study will provide evidence regarding the performance of SEVs and BEVs in patients with AAD who undergo TAVR.

TRIAL REGISTRATION: ClinicalTrials.gov NCT06009588. Registered on August 12, 2023.