Comparison of Self- and Balloon-expandable Valves in Patients With Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement: The AAD-CHOICE

National Center for Cardiovascular Diseases

Status: Enrolling

Conditions: Ascending Aortic Dilatation; Aortic Stenosis

Treatments: Device: self-expandable valves; Device: balloon-expandable valves

Study type: Interventional

Funder types: Other

Identifiers

NCT06009588

2023-2024

Details and patient eligibility

About

This study aimed at comparing the performance of self-expandable valves versus balloon-expandable valves in patients with ascending aortic dilation undergoing transcatheter aortic valve replacement.

Full description

Ascending aortic (AA) dilation is a common feature in patients with aortic stenosis (AS), especially in those with bicuspid aortic valve (BAV). For patients undergoing surgical aortic valve replacement (SAVR), current guidelines recommend concomitant aortic repair or replacement if the diameter of AA exceeds 45mm to avoid aortic dissection or rupture.

Transcatheter aortic valve replacement (TAVR) has profoundly changed the clinical management of AS patients who cannot tolerate SAVR. For patients who are candidates for TAVR, simultaneous repair of a dilated AA can be technically difficult. The safety and feasibility of the procedure and the fate of AA after the procedure in these patients remain unclear. Moreover, there are limited data comparing the performance of self-expandable valves versus balloon-expandable valves in these patients. The aim of the present study is to evaluate the impact of type of transcatheter heart valves on intra-procedural device success and post-procedural AA progression in patients with dilated AA (≥45mm) undergoing TAVR.

Enrollment: 100 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Severe aortic stenosis;
• Transfemoral access;
• Preoperative aortic CT suggesting maximum ascending aortic diameter ≥45mm and <55mm;
• Anticipated life expectancy >1 year;
• Age ≥ 65 years.

Exclusion criteria

• Dominant aortic regurgitation,;
• A history of SAVR or TAVR;
• A history of aortic surgery;
• Emergent TAVR.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Self-expandable valve group

Experimental group

Description:

Patients using self-expandable valves

Treatment:

Device: self-expandable valves

Balloon-expandable valve group

Experimental group

Description:

Patients using balloon-expandable valves

Treatment:

Device: balloon-expandable valves