Evaluating Transcatheter Aortic Valve Replacement for Severe Aortic Valve Regurgitation
Official title: Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation: a Real-world, Prospective, Multicenter Study (TRUST TAVR Registry)
Run by Xijing Hospital · NCT06381271 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 1 site (Xi'an, Shannxi) |
| Status | Recruiting |
| Started | October 30, 2018 |
| Main results expected | October 2034 |
| Study ends | October 2034 |
| Registry record updated | April 24, 2024 |
| Trial ID | NCT06381271 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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Xijing Hospital
Xi'an, Shannxi, China Recruiting
Study contacts
- Study coordinator: Rutao Wang, M.D, Ph.D
- Email: rutaowang@qq.com
- Phone: +86-15091095796
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Tracking progression and consequences of heart valve disease
This project will follow adults with moderate or worse valve disease to see if clinical tests and imaging can predict when their condition will get worse.
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Evaluating heart recovery after surgery for aortic regurgitation
This study looks at how heart surgery for aortic regurgitation helps people with heart problems feel better and recover by checking their heart function and quality of life afterward.
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Optimizing heart valve function using echocardiography or catheterization after valve replacement
This study is testing whether using ultrasound or a catheter to check heart valve function after a replacement helps patients with aortic valve problems feel better and have better outcomes.
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Comparing early aortic valve surgery to watchful waiting for severe asymptomatic aortic regurgitation
This study tests whether early surgery or just monitoring is better for people with severe aortic regurgitation who don't have symptoms, to see which option helps their heart health more.
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Evaluation of a new device for measuring aortic valve repair
This study is testing a new tool that helps surgeons measure aortic valve parts during repairs to see if it makes the surgery safer and more effective, especially for those who are still learning.
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A quick 10-minute heart scan for cardiac diseases
This study is testing a quick 10-minute heart scan to see if it can help diagnose heart problems better and faster for many patients without needing special dyes.
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.