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

NCT06009588 | Recruiting DMC

• 1 other identifier: 2023-2024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis; Ascending Aortic Dilatation

Keywords

Transcatheter aortic valve replacement; Self-expandable valve; Balloon-expandable valve

Outcome Measures

Primary Outcomes (3)

• 30-day all-cause mortality

  all-cause mortality within 30 days after TAVR procedure

  30 days after TAVR procedure

• 30-day adverse aortic events

  aortic death, aortic dissection, or aortic rupture

  30 days after TAVR procedure

• The rate of device success

  Device success is defined as following: 1. Technical success (Freedom from mortality; Successful access, delivery of the device, and retrieval of the delivery system; Correct positioning of a single prosthetic heart valve into the proper anatomical location; Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication) 2. Freedom from mortality 3. Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication 4. Intended performance of the valve (mean gradient \<20 mmHg, peak velocity \<3 m/s, Doppler velocity index $0.25, and less than moderate aortic regurgitation)

  30 days

Secondary Outcomes (5)

• 1-year all-cause mortality

  1 year after TAVR procedure

• 1-year cardiovascular mortality

  1 year after TAVR procedure

• 1-year adverse aortic events

  1 year after TAVR procedure

• Ascending aortic diameter expansion rate ≥3mm/year

  1 year after TAVR procedure

• Hospitalization (or re-hospitalization)

  1 year after TAVR procedure

Study Arms (2)

Self-expandable valve group

EXPERIMENTAL

Patients using self-expandable valves

Device: self-expandable valves

Balloon-expandable valve group

EXPERIMENTAL

Patients using balloon-expandable valves

Device: balloon-expandable valves

Interventions

self-expandable valves DEVICE

patients undergoing TAVR use self-expandable valves

Self-expandable valve group

balloon-expandable valves DEVICE

patients undergoing TAVR use balloon-expandable valves

Balloon-expandable valve group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Severe aortic stenosis;
• Transfemoral access;
• Preoperative aortic CT suggesting maximum ascending aortic diameter ≥45mm and \<55mm;
• Anticipated life expectancy \>1 year;
• Age ≥ 65 years.

You may not qualify if:

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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, 100037, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 33888385 BACKGROUND

• 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 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Xiangbin Pan, MD

  Department of Structural Heart Disease, National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kang An, MD

CONTACT

0085-15801301740; ankang913@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Surgeons are aware of randomisation results, however, participants and research staff are all blinded to the randomisation schemes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Self-expandable valve group vs. Balloon-expandable valve group

Study Record Dates

• First Submitted: August 12, 2023
• First Posted: August 24, 2023
• Study Start: August 31, 2023
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: August 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)