Actively Recruiting
Efficacy of Self-expandable and Balloon-expandable Valves in Patients With Ascending Aortic Dilation
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
This study evaluated the efficacy of self-expandable valves and balloon-expandable valves in patients with ascending aortic dilation who undergo transcatheter aortic valve replacement.
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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