Anatomical Determinants and Outcomes of Small Annulus Patients Undergoing TAVR in Different ASIAN Ethnicity

NCT07240025 | Enrolling By Invitation

• 1 other identifier: ADAPT-ASIAN
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Transcatheter aortic valve implantation (TAVI) presents unique challenges for Asian patients compared to Caucasians, largely due to the prevalence of small aortic annulus (SAA) defined based on Caucasians' data (430 mm²), bicuspid aortic valve (BAV), and substantial calcium deposits. No universally accepted cutoff value for defining SAA exists among Asian patients, who tend to have smaller body-built, resulting in inconsistencies across various studies. For the new-generation 20-/23-mm balloon expandable valve, a SAA is categorized as \<330 mm². Additionally, Asian Japanese patients have been identified to have extremely SAA (\<314 mm²), associated with unexpectedly larger residual transvalvular gradients following TAVI. Previous research on patient prosthesis mismatch (PPM) impact within the Asian population has also shown inconsistency. The OCEAN-TAVI registry with 1,546 Japanese patients found no significant differences in one-year all-cause and cardiovascular mortality between PPM and non-PPM groups. A study on the Sapien 3 balloon expandable valve in patients with SAA (\<430 mm²) found comparable clinical outcomes to non-SAA patients up to five years post-procedure, consistent with findings from a South Korean study. However, a Taiwan study involving 201 patients with PPM indicated higher rates of adverse outcomes at mid-term follow-up. Moreover, TAVI with self-expanding valves (SEV) has shown improved hemodynamic outcomes and reduced PPM incidence compared to balloon expandable valves (BEV) in patients with extreme SAA. To date, research on inter-racial differences in TAVI among Asian populations is lacking. This multicenter registry aims to evaluate SEV versus BEV outcomes in diverse Asian patients, particularly those with extreme SAA, and to address ethnic-specific challenges in TAVI.

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

• Bioprosthetic Structural Valve Dysfunction (SVD) at 12 months

  12 months Post-Operation

Secondary Outcomes (10)

• Mortality rate

  Mortality of patients 12 months post-operation

• Disabling stroke rate

  Rate of disabling stroke 12 months post-operation

• Heart failure re-hospitalization rate

  Heart failure re-hospitalization rate at 12 month post-operation

• Rate of moderate prosthesis-patient mismatch (PPM)

  Rate of moderate prosthesis-patient mismatch (PPM) at 12 month post-operation

• Rate of severe prosthesis-patient mismatch (PPM)

  Rate of severe prosthesis-patient mismatch (PPM) at 12 month post-operation

Study Arms (7)

AS TAVI patient in Prince of Wales Hospital

AS TAVI patient in Sarawak Heart Centre/University Malaysia Sarawak

AS TAVI patient in National Heart Centre Malaysia

AS TAVI patient in King Chulalongkorn Memorial Hospital

AS TAVI patient in Ramathibodi Hospital

AS TAVI patient in St. Luke's Medical Cente

AS TAVI patient in Sapporo Cardiovascular Clinic

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Retrospective data collection will be carried out at multiple TAVI sites in Asia. Patients with severe AS who underwent TAVI (SEV/ BEV) will be identified from retrospective records (Physical/ Electronic). Consecutive patients who underwent pre-procedural computed tomography (CT) scans for aortic valve evaluation from 2018-1-1 to 2024-12-31 were included.

You may qualify if:

• Aortic Stenosis patients treated with Transcatherter Aortic Valve Intervention

You may not qualify if:

• Transcatherter Aortic Valve Intervention for pure Aortic Regurgitation
• Emergent procedure for any reason;
• Previous aortic valve replacement

Sponsors & Collaborators

• Prince of Wales Hospital, Shatin, Hong Kong: lead
• Sarawak Heart Centre: collaborator
• King Chulalongkorn Memorial Hospital: collaborator
• Ramathibodi Hospital: collaborator
• University Malaysia Sarawak: collaborator
• St. Luke's Medical Center, Philippines: collaborator
• Sapporo Heart Center: collaborator

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Shatin, 0000, Hong Kong

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Chak Yu Kent So, Clinicnal Assistant Professor

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

HK (1)