Clinical trial Recruiting at 1 site Observational Ages 18 and up

Evaluating the safety and effectiveness of transcatheter aortic valves in Chinese patients

Official title: RECORD TAVR REGISTRY: Prospective, Multi-Center Registry of "Real World" Chinese Patients Undergoing Transcatheter Aortic Valve Replacement

Run by Xijing Hospital · NCT06257043 · Data updated 2026-11-12

This study is testing how safe and effective a new heart valve treatment is for older Chinese patients with aortic stenosis over the next 10 years.

More Aortic Valve Disease trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment3000 (estimated)
SponsorXijing Hospital
Academic / other
Locations1 site (Xi'an, Shaanxi)
StatusRecruiting
StartedOctober 30, 2023
Main results expectedNovember 1, 2033
Study endsJanuary 1, 2034
Registry record updatedApril 19, 2024
Trial IDNCT06257043 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include elderly patients with aortic valve disease who are evaluated by a cardiac team and deemed suitable for TAVR therapy.

Probably not a fit

Patients who are considered unsuitable for TAVR by a cardiac team or those who cannot tolerate the study materials or medications may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry aims to collect clinical baseline, procedural, and follow-up data from patients treated with transcatheter aortic valve replacement (TAVR) across multiple centers in China. The study will evaluate short-, mid-, and long-term clinical outcomes of post-marketing transcatheter valves, addressing a significant gap in knowledge regarding TAVR efficacy and safety in the Chinese population. With a focus on elderly patients suffering from aortic stenosis, the study will track outcomes for up to 10 years to provide valuable insights into this treatment option. The findings will help validate TAVR's use in a population that has not been extensively studied before.

Why it matters

Potential benefit: If successful, this study could provide critical data to improve treatment strategies for patients with aortic valve disease in China.

How similar studies have gone: While TAVR has been studied extensively in Western populations, this study is novel as it focuses on the Chinese population, where large-scale data on TAVR outcomes is currently lacking.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Patients with aortic valve disease are evaluated by the cardiac team and indicate TAVR therapy
2. Patients who understand the purpose of this study, voluntarily participate in the trial and sign the informed consent form

Exclusion Criteria:

1. Patients with aortic valve disease who have been evaluated by a cardiac team as unsuitable for TAVR
2. Patients who cannot tolerate the materials or medications associated with this study
3. Women who are pregnant or breastfeeding
4. Patients who participated in a clinical trial of another drug or medical device before enrollment

Where it's running

  • Ling Tao
    Xi'an, Shaanxi, China
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.