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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 3000 (estimated) |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 1 site (Xi'an, Shaanxi) |
| Status | Recruiting |
| Started | October 30, 2023 |
| Main results expected | November 1, 2033 |
| Study ends | January 1, 2034 |
| Registry record updated | April 19, 2024 |
| Trial ID | NCT06257043 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
- Study coordinator: Rutao Wang, M.D, Ph.D
- Email: rutaowang@qq.com
- Phone: +86-15091095796
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.