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

Aortic Stenosis Clinical Trial

— PROSPERO-TAVI  

Official title:

PRogression Of bicuSPid-rElated aoRtOpathy in Patients Undergoing Transcatheter Aortic Valve Implantation: The PROSPERO-TAVI Multi Center, International Registry

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06248294
• Other study ID #: UCatania003
• Status: Not yet recruiting
• Start date: February 1, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: January 2024
• Source: University of Catania
• Contact: Giuliano Costa, MD
• Phone: 3934721874329
• Email: giulianocosta90[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: January 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Bicuspid Aortic Valve Disease

Intervention

Diagnostic Test:
• CT follow-up
Computed tomography angiography assessment of BAV-related aorthopathy

Locations

Country	Name	City	State
Italy	AOU Policlinico G. Rodolico - San Marco	Catania

Sponsors (1)

Lead Sponsor	Collaborator
University of Catania

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute difference in maximum aortic diameters at multiple levels of ascending aorta	Measurements of maximum aortic diameters at follow-up CTA assessment will be compared with values at pre-TAVI CTA assessment	5 years
Secondary	Death, stroke or rehospitalization for heart failure	Death, stroke or rehospitalization for heart failure	5 years
Secondary	Aortic events leading to urgent intervention or elective aortic root replacement	Aortic events (i.e. fissuration, dissection) after the index intervention leading to aortic intervention, or elective aortic root replacement.	5 years
Secondary	Bioprosthesis dysfunction (HALT or RLM at 4-D CTA assessment)	Presence of hypo-attenuated leaflet thickening (HALT)/reduced leaflet motion (RLM) at follow-up four-dimensional CTA assessment	5 years