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

National Center for Cardiovascular Diseases

Status: Enrolling

Conditions: Ascending Aortic Dilatation; Aortic Stenosis

Treatments: Device: Transcatheter aortic valve replacement

Study type: Interventional

Funder types: Other

Identifiers

NCT06743568

2024-2486

Details and patient eligibility

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Self-expandable valve group

Other group

Description:

Patients who undergo transcatheter aortic valve replacement using self-expandable valves

Treatment:

Device: Transcatheter aortic valve replacement

Balloon-expandable valve group

Other group

Description:

Patients who undergo transcatheter aortic valve replacement using balloon-expandable valves

Treatment:

Device: Transcatheter aortic valve replacement