Assessing changes in aortic diameter after valve replacement
Official title: Changes of Ascending Aortic Diameter in Patients Undergoing Transcatheter Aortic Valve Replacement
Run by China National Center for Cardiovascular Diseases · NCT05739253 · Data updated 2026-11-12
This study looks at how the size of the aorta changes after patients have a heart valve replacement to see if it gets bigger or stays the same, especially for those who already had a larger aorta.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 480 (estimated) |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | March 22, 2022 |
| Main results expected | March 21, 2025 |
| Study ends | March 21, 2025 |
| Registry record updated | February 10, 2025 |
| Trial ID | NCT05739253 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with severe aortic stenosis who are symptomatic and at high risk for surgical valve replacement.
✕Probably not a fit
Patients with dominant aortic regurgitation or those who have previously undergone aortic valve replacement or surgery 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 study evaluates the changes in ascending aortic diameter in patients undergoing transcatheter aortic valve replacement (TAVR). It aims to determine whether the diameter increases or remains stable post-procedure, particularly in patients with pre-existing aortic dilatation. Additionally, the study seeks to identify factors that contribute to postoperative aortic dilatation. By refining risk stratification for TAVR candidates, this research could enhance patient outcomes.
Why it matters
Potential benefit: If successful, this study could improve risk assessment and management strategies for patients undergoing TAVR.
How similar studies have gone: While similar studies have explored aortic diameter changes, this specific focus on TAVR and its implications for aortic dilatation is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Severe aortic stenosis defined as an aortic valve area of 1cm2 or less or an indexed aortic valve area of 0.6cm2/m2 or less; * Presence of clinical symptoms defined as a New York Heart Association functional class of 2 or more; * High risk of surgical aortic valve replacement; * Suitability for a transfemoral vascular access. Exclusion Criteria: * Dominant aortic regurgitation; * History of surgical or transcatheter aortic valve replacement; * History of aortic surgery; * Connective tissue disorders.
Where it's running
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National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Xiangbin Pan, Dr
- Email: panxiangbin@fuwaihospital.org
- Phone: 0086-010-88396666
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Comparing self-expandable and balloon-expandable valves for aortic dilation treatment
This study is testing whether self-expandable or balloon-expandable valves work better for people with aortic dilation who are getting a heart valve replacement.
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Exercise and nutrition support before and after TAVI for older adults with aortic stenosis
This trial tests whether a personalized exercise program plus protein and iron supplements before and after a transcatheter valve replacement can help older adults with aortic stenosis recover better than standard care.
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Association Between Aortic Valve Area Changes and Pulmonary Congestion After TAVI
This study tests whether improvements in aortic valve opening after TAVI relate to reductions in lung congestion measured by ultrasound in adults with severe aortic stenosis.
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Systematic 14-day ambulatory heart monitoring after TAVI
After TAVI, patients with certain heart conduction abnormalities will try 14 days of wearable ECG monitoring to see if it lowers the chances of sudden death, symptomatic heart rhythm problems, or stroke within a year compared to standard follow-up.
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Echo-AVCS: Drawing AI-powered clues from heart scans to confirm severe aortic stenosis
This study tests an AI-based echocardiography score to help confirm severe aortic stenosis in adults who are also getting CT calcium scoring.
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TAVI without on-site heart surgery: can selected centers do it safely?
This trial tests whether transcatheter aortic valve implantation can be done safely in certain hospitals that don’t have on-site cardiac surgery, for patients with severe aortic stenosis who are appropriately selected.
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.