Aortic StenosisNCT07240025
Anatomical Determinants and Outcomes of Small Annulus Patients Undergoing TAVR in Different ASIAN Ethnicity
An observational study of Aortic Stenosis, run by Prince of Wales Hospital, Shatin, Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Stenosis
- How many people
- 31 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2025to 30 Jun 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Aortic Stenosis patients treated with Transcatherter Aortic Valve Intervention
Who cannot join
- Transcatherter Aortic Valve Intervention for pure Aortic Regurgitation
- Emergent procedure for any reason;
- Previous aortic valve replacement
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AS TAVI patient in Prince of Wales Hospital | Not described | |
| AS TAVI patient in Sarawak Heart Centre/University Malaysia Sarawak | Not described | |
| AS TAVI patient in National Heart Centre Malaysia | Not described | |
| AS TAVI patient in King Chulalongkorn Memorial Hospital | Not described | |
| AS TAVI patient in Ramathibodi Hospital | Not described | |
| AS TAVI patient in St. Luke's Medical Cente | Not described | |
| AS TAVI patient in Sapporo Cardiovascular Clinic | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioprosthetic Structural Valve Dysfunction (SVD) at 12 months
Measured: 12 months Post-Operation
Secondary outcomes (10)
Mortality rate
Measured: Mortality of patients 12 months post-operation
Disabling stroke rate
Measured: Rate of disabling stroke 12 months post-operation
Heart failure re-hospitalization rate
Measured: Heart failure re-hospitalization rate at 12 month post-operation
Rate of moderate prosthesis-patient mismatch (PPM)
In patients with a body mass index <30 kg/m2, PPM was defined as none or mild if the indexed EOA (iEOA) was>0.85 cm2/m2, moderate if the iEOA was 0.85-0.66 cm2/m2 and severe if the iEOA was ≤0.65 cm2/m2. In patients with a body mass index ≥30 kg/m2, PPM was defined as none or mild if the iEOA was>0.70 cm2/m2, moderate if the iEOA was 0.56-0.70 cm2/m2 and severe if the iEOA was ≤0.55 cm2/m2
Measured: Rate of moderate prosthesis-patient mismatch (PPM) at 12 month post-operation
Rate of severe prosthesis-patient mismatch (PPM)
Measured: Rate of severe prosthesis-patient mismatch (PPM) at 12 month post-operation
Device success rate
Measured: Device success rate at 30-days post-operation
Device safety rate
Measured: Device safety rate at 30-days post-operation
Rate of Bioprosthetic Structural Valve Dysfunction
Measured: Bioprosthetic Structural Valve Dysfunction (SVD) at follow-up
Rate of endocarditis
Measured: Rate of endocarditis at 12 month
Rate of Non-structural valve dysfunction (NSVD)
≥Moderate aortic regurgitation rate of moderate or severe PPM (PPM: In patients with a body mass index <30 kg/m2, PPM was defined as none or mild if the indexed EOA (iEOA) was>0.85 cm2/m2, moderate if the iEOA was 0.85-0.66 cm2/m2 and severe if the iEOA was ≤0.65 cm2/m2. In patients with a body mass index ≥30 kg/m2, PPM was defined as none or mild if the iEOA was>0.70 cm2/m2, moderate if the iEOA was 0.56-0.70 cm2/m2 and severe if the iEOA was ≤0.55 cm2/m2, PVL, and DVI (severe <0.25, moderate 0.25-0.5, mild >0.5)
Measured: Rate of Non-structural valve dysfunction (NSVD) at 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Jun 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Sarawak Heart Centre, King Chulalongkorn Memorial Hospital, Ramathibodi Hospital, University Malaysia Sarawak, St. Luke's Medical Center, Philippines, Sapporo Heart Center
- Responsible party
- Principal investigator, Dr So Chak Yu kent, Prince of Wales Hospital, Shatin, Hong Kong
- Investigators
- Chak Yu Kent So, Clinicnal Assistant Professor, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240025
- Sponsor's protocol ID
- ADAPT-ASIAN
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided