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

Not yet recruiting

• Conditions: Aortic Stenosis; Bicuspid-related Aortopathy
• Interventions: Diagnostic Test: CT follow-up

• Registration Number: NCT06248294
• Lead Sponsor: University of Catania

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-20
• Study First Submitted QC: 2024-01-30
• Last Update Submitted: 2024-01-30
• Study Start: 2024-02-01
• Study First Posted: 2024-02-08
• Last Update Posted: 2024-02-08
• Primary Completion: 2024-12-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TAVI patients with native BAV	CT follow-up	Patients undergoing TAVI for severe aortic stenosis and native bicuspid aortic valve

Primary Outcome Measures

Name	Time	Method
Absolute difference in maximum aortic diameters at multiple levels of ascending aorta	5 years	Measurements of maximum aortic diameters at follow-up CTA assessment will be compared with values at pre-TAVI CTA assessment

Secondary Outcome Measures

Name	Time	Method
Bioprosthesis dysfunction (HALT or RLM at 4-D CTA assessment)	5 years	Presence of hypo-attenuated leaflet thickening (HALT)/reduced leaflet motion (RLM) at follow-up four-dimensional CTA assessment
Death, stroke or rehospitalization for heart failure	5 years	Death, stroke or rehospitalization for heart failure
Aortic events leading to urgent intervention or elective aortic root replacement	5 years	Aortic events (i.e. fissuration, dissection) after the index intervention leading to aortic intervention, or elective aortic root replacement.

Trial Locations

Locations (1)

AOU Policlinico G. Rodolico - San Marco; 🇮🇹 Catania, Italy