PRogression Of bicuSPid-rElated aoRtOpathy in Patients Undergoing Transcatheter Aortic Valve Implantation (PROSPERO-TAVI)

University of Catania

Status: Not yet enrolling

Conditions: Bicuspid-related Aortopathy; Aortic Stenosis

Treatments: Diagnostic Test: CT follow-up

Study type: Observational

Funder types: Other

Identifiers

NCT06248294

UCatania003

Details and patient eligibility

About

Transcatheter aortic valve implantation (TAVI) is being offered to younger patients affected by severe aortic stenosis as an alternative to surgery. Although historically excluded from the main randomized clinical trials, patients with native bicuspid aortic valve (BAV) are commonly treated in daily TAVI practice. Indeed, several observational studies reported similar outcomes of TAVI in BAV patients compared to tricuspid aortic valve (TAV) patients. Notably, BAV is frequently associated with aortic dilatation (20% to 84% of BAV patients). Surgical patients usually undergo concomitant aortic root replacement if aortic diameter exceed 50 mm (5). TAVI patients do not undergo treatment of the concomitant aortopathy, but currently there is a paucity of data regarding the progression of the aortopathy after AS treatment (6,7).

The main aim of this ambispective, multicenter study is to evaluate the progression of the bicuspid valve-associated aortopathy in patients undergoing TAVI by computed tomography angiography (CTA) assessment at follow-up.

Enrollment: 300 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing TAVI with native BAV from January 2018 to December 2019

Exclusion criteria

• Patients undergoing TAVI without native BAV
• Patients receiving first generation TAVI device
• Patients undergoing TAVI before January 2018 or after December 2019

Trial design

300 participants in 1 patient group

TAVI patients with native BAV

Description:

Patients undergoing TAVI for severe aortic stenosis and native bicuspid aortic valve

Treatment:

Diagnostic Test: CT follow-up