NCT06743568

Efficacy of Self-expandable and Balloon-expandable Valves in Patients With Ascending Aortic Dilation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Ascending aortic dilation (AAD) is a common feature in patients with aortic stenosis, especially in those with bicuspid aortic valve. According to the 2022 AHA/ACC Guideline for the Diagnosis and Management of Aortic Disease, in patients undergoing surgical aortic valve replacement who have a concomitant AAD with a maximum diameter of ≥45mm, ascending aortic replacement is reasonable when performed by experienced surgeons in a Multidisciplinary Aortic Team (Class 2a, Level B-NR). However, in patients undergoing transcatheter aortic valve replacement, the impact of ascending aortic dilation remains unclear. Therefore, we designed this multicenter prospective randomized controlled trial, aiming to assess the efficacy of self-expandable and balloon-expandable valves in patients with AAD with a maximum diameter of ≥45mm.

Conditions

• Aortic Stenosis
• Ascending Aortic Dilatation

Interventions

Type	Name	Description
DEVICE	Transcatheter aortic valve replacement	Eligible patients will be randomized 1:1 to self-expandable valve group or balloon-expandable valve group.

Timeline

• Start date: 2024-10-15
• Primary completion: 2026-07-31
• Completion: 2027-07-31
• First posted: 2024-12-20
• Last updated: 2024-12-20

Locations

3 sites across 1 country: China