Assessing changes in aortic diameter after valve replacement
Changes of Ascending Aortic Diameter in Patients Undergoing Transcatheter Aortic Valve Replacement
China National Center for Cardiovascular Diseases · NCT05739253
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 |
|---|---|
| Enrollment | 480 (estimated) |
| Sex | All |
| Sponsor | China National Center for Cardiovascular Diseases (other gov) |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05739253 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with severe aortic stenosis who are symptomatic and at high risk for surgical valve replacement.
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.
Why it matters
Potential benefit: If successful, this study could improve risk assessment and management strategies for patients undergoing TAVR.
How similar studies have performed: While similar studies have explored aortic diameter changes, this specific focus on TAVR and its implications for aortic dilatation is relatively novel.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality
- 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
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.
Conditions: Aortic Stenosis, Ascending Aortic Dilatation, Bicuspid Aortic Valve, Transcatheter aortic valve replacement, Ascending aortic diameter, Ascending aortic dilatation, Bicuspid aortic valve