Early access
Sign in
Enrolling by invitationNo phase

Valve replacement outcomes in Asian people with aortic stenosis and a small valve ring

Compares two kinds of replacement valves in Asian people with aortic stenosis.

Key facts

Who runs it
Prince of Wales Hospital, Shatin, Hong Kong
Where
Hong Kong1 site in 1 countryChoose a country to see its sites
Trial code
Registry title
Anatomical Determinants and Outcomes of Small Annulus Patients Undergoing TAVR in Different ASIAN Ethnicity
Status
Enrolling by invitation
People taking part
31 people, planned
Started
1 Jun 2025
Expected to end
30 Jun 2028
Type of study
Observational, 7 groups
Record updated
25 November 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with aortic stenosis (a narrowed heart valve) who were treated with TAVI, a valve replacement done through a tube in a blood vessel. It studies Asian patients, especially those with a small valve ring (annulus).

Sex
All sexes can join.
Disease stage
Aortic stenosis treated with TAVI.
Earlier treatment
People who had an aortic valve replacement before cannot join.

Main reasons for not taking part

  • TAVI done only for a leaking aortic valve (pure aortic regurgitation)
  • Emergency procedure for any reason
  • Previous aortic valve replacement

The registry criteria, word for word

Show all 4 criteriaShow less

Who can take part

  • Aortic Stenosis patients treated with Transcatherter Aortic Valve Intervention

Who cannot take part

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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 7 groups in the trial

  • 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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Anatomical Determinants and Outcomes of Small Annulus Patients Undergoing TAVR in Different ASIAN Ethnicity
Plain-language title
Valve replacement outcomes in Asian people with aortic stenosis and a small valve ringGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
25 November 2025