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Enrolling by Invitation

NCT Number: NCT07240025

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince of Wales Hospital

Hong Kong, Shatin, 0000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aortic Stenosis patients treated with Transcatherter Aortic Valve Intervention

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Bioprosthetic Structural Valve Dysfunction (SVD) at 12 months

    Time frame: 12 months Post-Operation

Secondary outcomes

  1. Mortality rate

    Time frame: Mortality of patients 12 months post-operation

  2. Disabling stroke rate

    Time frame: Rate of disabling stroke 12 months post-operation

  3. Heart failure re-hospitalization rate

    Time frame: Heart failure re-hospitalization rate at 12 month post-operation

  4. Rate of moderate prosthesis-patient mismatch (PPM)

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

    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

  5. Rate of severe prosthesis-patient mismatch (PPM)

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

  6. Device success rate

    Time frame: Device success rate at 30-days post-operation

  7. Device safety rate

    Time frame: Device safety rate at 30-days post-operation

  8. Rate of Bioprosthetic Structural Valve Dysfunction

    Time frame: Bioprosthetic Structural Valve Dysfunction (SVD) at follow-up

  9. Rate of endocarditis

    Time frame: Rate of endocarditis at 12 month

  10. Rate of Non-structural valve dysfunction (NSVD)

    Time frame: Rate of Non-structural valve dysfunction (NSVD) at 12 month

    ≥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)

Sponsors and collaborators

Lead sponsor

Prince of Wales Hospital, Shatin, Hong Kong

Other

Collaborators

  • King Chulalongkorn Memorial Hospital
  • Ramathibodi Hospital
  • Sapporo Heart Center
  • Sarawak Heart Centre
  • St. Luke's Medical Center, Philippines
  • University Malaysia Sarawak

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 20, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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