Evaluating the safety and effectiveness of transcatheter aortic valves in Chinese patients
RECORD TAVR REGISTRY: Prospective, Multi-Center Registry of "Real World" Chinese Patients Undergoing Transcatheter Aortic Valve Replacement
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 |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT06257043 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include elderly patients with aortic valve disease who are evaluated by a cardiac team and deemed suitable for TAVR therapy.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Xi'an, Shaanxi
- Ling Tao — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Study coordinator: Rutao Wang, M.D, Ph.D
- Email: rutaowang@qq.com
- Phone: +86-15091095796
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.