Efficacy of Self-expandable and Balloon-expandable Valves in Patients With Ascending Aortic Dilation
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
RECRUITING
Beijing
Fuwai Yunnan Cardiovascular Hospital
NOT_YET_RECRUITING
Kunming
Fuwai Shenzhen Hospital
NOT_YET_RECRUITING
Shenzhen
Contact Information
Primary
Kang An, MD
ankang913@126.com
+86-15801301740
Time Frame
Start Date: 2024-10-15
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 100
Treatments
Other: Self-expandable valve group
Patients who undergo transcatheter aortic valve replacement using self-expandable valves
Other: Balloon-expandable valve group
Patients who undergo transcatheter aortic valve replacement using balloon-expandable valves
Related Therapeutic Areas
Sponsors
Leads: China National Center for Cardiovascular Diseases