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临床试验/NCT07240025
NCT07240025Enrolling By Invitation不适用

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

Prince of Wales Hospital, Shatin, Hong Kong1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2025年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
31
试验地点
1
主要终点
Bioprosthetic Structural Valve Dysfunction (SVD) at 12 months

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Aortic Stenosis patients treated with Transcatherter Aortic Valve Intervention

排除标准

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

结局指标

主要结局

Bioprosthetic Structural Valve Dysfunction (SVD) at 12 months

时间窗: 12 months Post-Operation

次要结局

  • Rate of moderate prosthesis-patient mismatch (PPM)(Rate of moderate prosthesis-patient mismatch (PPM) at 12 month post-operation)
  • Device success rate(Device success rate at 30-days post-operation)
  • Device safety rate(Device safety rate at 30-days post-operation)
  • Rate of Bioprosthetic Structural Valve Dysfunction(Bioprosthetic Structural Valve Dysfunction (SVD) at follow-up)
  • Rate of endocarditis(Rate of endocarditis at 12 month)
  • 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 severe prosthesis-patient mismatch (PPM)(Rate of severe prosthesis-patient mismatch (PPM) at 12 month post-operation)
  • Rate of Non-structural valve dysfunction (NSVD)(Rate of Non-structural valve dysfunction (NSVD) at 12 month)

研究者

发起方
Prince of Wales Hospital, Shatin, Hong Kong
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr So Chak Yu kent

Clinical Assistant Professor

Prince of Wales Hospital, Shatin, Hong Kong

研究点 (1)

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