Clinical trial NCT06009588: Comparison of Self- and Balloon-expandable Valves in Patients With Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement: The AAD-CHOICE
Official title: Comparison of Self- and Balloon-expandable Valves in Patients With Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement: The AAD-CHOICE
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Stenosis
Ascending Aortic Dilatation
Keywords: Transcatheter aortic valve replacement
Self-expandable valve
Balloon-expandable valve
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2023-08-24
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Self-expandable valve group vs. Balloon-expandable valve group
Primary purpose: TREATMENT

Brief 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.

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.

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.

Primary outcomes:
measure: 30-day all-cause mortality
timeFrame: 30 days after TAVR procedure
measure: 30-day adverse aortic events
timeFrame: 30 days after TAVR procedure
measure: The rate of device success
timeFrame: 30 days
Secondary outcomes:
measure: 1-year all-cause mortality
timeFrame: 1 year after TAVR procedure
measure: 1-year cardiovascular mortality
timeFrame: 1 year after TAVR procedure
measure: 1-year adverse aortic events
timeFrame: 1 year after TAVR procedure
measure: Ascending aortic diameter expansion rate ≥3mm/year
timeFrame: 1 year after TAVR procedure
measure: Hospitalization (or re-hospitalization)
timeFrame: 1 year after TAVR procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
state: Beijing
Study officials:
affiliation: Department of Structural Heart Disease, National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
name: Xiangbin Pan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 1;77(21):2717-2746. doi: 10.1016/j.jacc.2021.02.038. Epub 2021 Apr 19.