Actively Recruiting
Efficacy of Self-expandable and Balloon-expandable Valves in Patients With Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement
Led by China National Center for Cardiovascular Diseases · Updated on 2024-12-20
100
Participants Needed
3
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effectiveness of two types of valves—self-expandable and balloon-expandable—in patients with ascending aortic dilation who are undergoing transcatheter aortic valve replacement (TAVR). This condition often occurs in people with aortic stenosis, especially those with a bicuspid aortic valve. While surgical guidelines exist for treating patients with this condition, the impact of ascending aortic dilation on TAVR outcomes is not well understood, prompting this multicenter randomized controlled trial. Participants eligible for the study will be randomly assigned to receive either a self-expandable valve or a balloon-expandable valve during their transcatheter aortic valve replacement procedure. The study focuses on patients with a maximum ascending aortic diameter between 45mm and 54mm. The treatment is delivered via transfemoral vascular access, and patients will be closely monitored during the perioperative period. Throughout the study, participants will be assessed for device success during the procedure, as well as for any adverse aortic events and all-cause mortality occurring within 30 days after treatment. Regular follow-up will help researchers evaluate the safety and performance of the valves in this patient group. The study includes patients aged 65 years and older who have a life expectancy exceeding 12 months, ensuring that long-term outcomes can be observed.
CONDITIONS
Official Title
Efficacy of Self-expandable and Balloon-expandable Valves in Patients With Ascending Aortic Dilation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Severe aortic stenosis with an aortic valve area of 1 cm2 or less or an indexed aortic valve area of 0.6 cm2/m2 or less
- Selected for transcatheter aortic valve replacement by a multidisciplinary heart team
- Maximum ascending aortic diameter between 45mm and 54mm on preoperative CT scan
- Anatomy suitable for transfemoral vascular access
- Life expectancy longer than 12 months
- Age 65 years or older
You will not qualify if you...
- Pure aortic regurgitation
- Previous surgical or transcatheter aortic valve replacement (valve-in-valve)
- History of any aortic surgery
- Emergency surgery
- Refusal to be randomized or inability to complete regular follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, China
Actively Recruiting
2
Fuwai Shenzhen Hospital
Shenzhen, Guangdong, China
Not Yet Recruiting
3
Fuwai Yunnan Cardiovascular Hospital
Kunming, Yunnan, China
Not Yet Recruiting
Research Team
K
Kang An, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here