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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)

Year: 2025

Type: article

Abstract: 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.

Source: Trials

DOI: 10.1186/s13063-025-09233-7

Authors: Kang An, Fengwen Zhang, Wenbin Ouyang, Shiguo Li, Xiangbin Pan

Institutions: Chinese Academy of Medical Sciences & Peking Union Medical College, Fu Wai Hospital, State Key Laboratory of Cardiovascular Disease, Kunming Medical University, Fuwai Yunnan Cardiovascular Hospital

Language: English

Topic: Cardiac Valve Diseases and Treatments

Subfield: Cardiology and Cardiovascular Medicine

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $2,790