Comparison of Self- and Balloon-expandable Valves in Patients With Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement: The AAD-CHOICE
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: self-expandable valves, balloon-expandable valves.
- Who it may be relevant to
- Registry conditions: Aortic Stenosis, Ascending Aortic Dilatation. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Detailed 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.
Interventions
- Device self-expandable valves
patients undergoing TAVR use self-expandable valves - Device balloon-expandable valves
patients undergoing TAVR use balloon-expandable valves
Primary outcome measures
- 30-day all-cause mortality [Time frame: 30 days after TAVR procedure]
- 30-day adverse aortic events [Time frame: 30 days after TAVR procedure]
- The rate of device success [Time frame: 30 days]
Secondary outcome measures (5)
- 1-year all-cause mortality [Time frame: 1 year after TAVR procedure]
- 1-year cardiovascular mortality [Time frame: 1 year after TAVR procedure]
- 1-year adverse aortic events [Time frame: 1 year after TAVR procedure]
- Ascending aortic diameter expansion rate ≥3mm/year [Time frame: 1 year after TAVR procedure]
- Hospitalization (or re-hospitalization) [Time frame: 1 year after TAVR procedure]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Med — Beijing
Publications
- VARC-3 WRITING COMMITTEE:; Genereux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research. J Am Coll Cardiol. 2021 Jun PMID 33888385
- An K, Zhang F, Ouyang W, Li S, Pan X. 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). Trials. 2025 Nov 28;27(1):1. doi: 10.1186/s13063-025-09233-7. PMID 41316413
Identifiers
NCT: NCT06009588 · 2023-2024