Comparing self-expandable and balloon-expandable valves for aortic dilation treatment
Efficacy of Self-expandable and Balloon-expandable Valves in Patients With Ascending Aortic Dilation
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 3 sites (Beijing, Beijing Municipality and 2 other locations) |
| Trial ID | NCT06743568 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of self-expandable versus balloon-expandable valves in patients with ascending aortic dilation undergoing transcatheter aortic valve replacement. Ascending aortic dilation is often seen in patients with aortic stenosis, particularly those with a bicuspid aortic valve. The trial is a multicenter, prospective randomized controlled design, focusing on patients with a maximum ascending aortic diameter of 45mm to 54mm. The goal is to clarify the impact of valve type on patient outcomes in this specific population.
Who should consider this trial
Good fit: Ideal candidates are patients aged 65 and older with severe aortic stenosis and an ascending aortic diameter between 45mm and 54mm.
Not a fit: Patients with pure aortic regurgitation or those who have previously undergone aortic valve replacement will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with aortic stenosis and ascending aortic dilation.
How similar studies have performed: While there have been studies on valve types in aortic procedures, this specific comparison in the context of ascending aortic dilation is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Severe AS defined as an aortic valve area (AVA) of 1cm2 or less or an indexed AVA of 0.6 cm2/m2 or less; * Evaluation and selection for TAVR by the multidisciplinary heart team; * Maximum ascending aortic diameter between 45mm and 54mm on preoperative contrast-enhanced computed tomography (CT) scan * Anatomic suitability for a transfemoral vascular access; * Life expectancy of more than 12 months; * Age ≥65 years. Exclusion Criteria: * Pure aortic regurgitation; * History of surgical or transcatheter aortic valve replacement (valve in valve); * History of any aortic surgery; * Emergent surgery; * Patients who refused to be randomized or unable to complete regular follow-up.
Where this trial is running
Beijing, Beijing Municipality and 2 other locations
- National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College — Beijing, Beijing Municipality, China (Recruiting)
- Fuwai Shenzhen Hospital — Shenzhen, Guangdong, China (Not_yet_recruiting)
- Fuwai Yunnan Cardiovascular Hospital — Kunming, Yunnan, China (Not_yet_recruiting)
Study contacts
- Study coordinator: Kang An, MD
- Email: ankang913@126.com
- Phone: +86-15801301740
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.