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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06248294
Other study ID # UCatania003
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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