Evaluating Transcatheter Aortic Valve Replacement for Severe Aortic Valve Regurgitation
Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation: a Real-world, Prospective, Multicenter Study (TRUST TAVR Registry)
This study is testing if a less invasive heart valve replacement procedure can safely help people with severe aortic valve regurgitation feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 1 site (Xi'an, Shannxi) |
| Trial ID | NCT06381271 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective observational registry aims to assess the safety and efficacy of transcatheter aortic valve replacement (TAVR) in patients with pure severe aortic valve regurgitation. The study will collect baseline characteristics, procedural, and clinical data to better understand the outcomes of TAVR in this patient population. Given the high mortality rates associated with conservative management and the limited use of surgical aortic valve replacement, this study seeks to provide insights into a less invasive treatment option for high-risk patients. The findings may help clarify the role of TAVR in treating severe aortic valve regurgitation, which is currently debated in the medical community.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with severe aortic valve regurgitation who are evaluated by a Heart team and deemed eligible for TAVR therapy.
Not a fit: Patients who are unable to provide informed consent, those treated with TAVR for aortic stenosis, or those participating in other clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive treatment option for patients with severe aortic valve regurgitation, potentially improving survival rates and quality of life.
How similar studies have performed: While there have been limited studies on TAVR for severe aortic valve regurgitation, the approach is relatively novel and has not been extensively tested in large-scale observational settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Patients diagnosed with severe aortic valve regurgitation undergo evaluation by the Heart team and are eligible for TAVR therapy. * 2\. Patients who understand the purpose of this study, agree to participate in the trial and sign the informed consent form Exclusion Criteria: * 1\. Patients who cannot provide informed consent * 2\. Patients who are treated with TAVR for aortic stenosis * 3\. Patients who are participating in other clinical trials
Where this trial is running
Xi'an, Shannxi
- Xijing Hospital — Xi'an, Shannxi, 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.