Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAVI patients with native BAV | Patients undergoing TAVI for severe aortic stenosis and native bicuspid aortic valve |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT follow-up | Diagnostic Test | Computed tomography angiography assessment of BAV-related aorthopathy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Death, stroke or rehospitalization for heart failure | Death, stroke or rehospitalization for heart failure | 5 years |
| Aortic events leading to urgent intervention or elective aortic root replacement |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Patients undergoing TAVI for severe aortic stenosis and native bicuspid aortic valve
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giuliano Costa, MD | Contact | 3934721874329 | giulianocosta90@gmail.com | |
| Marco Barbanti, MD | Contact | 393283026464 | mbarbanti83@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Policlinico G. Rodolico - San Marco | Catania | 95123 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42208924 | Derived | Costa G, Laterra G, Sammartino S, De Backer O, Jia Y, Pilgrim T, Daijiro T, Montorfano M, Ancona F, Bellini B, Redwood S, Patterson T, Kornowski R, Hamdan A, Mylotte D, Del Sole PA, Saia F, Palmierini T, Bedogni F, Gandolfo C, Cannata S, Garot P, Gall E, De Carlo M, Angelillis M, Imme S, Tamburino C, Mangieri A, Tartaglia F, Nombela L, Santos IA, Gomez MG, Attizzani G, Frazzetto M, Cali M, Millar K, Webb J, Barbanti M. Progression of bicuspid-related aortopathy in patients undergoing transcatheter aortic valve implantation: Rationale and design of the international, multicenter PROSPERO-TAVI registry. Am Heart J. 2026 May 27;300:107494. doi: 10.1016/j.ahj.2026.107494. Online ahead of print. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Aortic events (i.e. fissuration, dissection) after the index intervention leading to aortic intervention, or elective aortic root replacement.
| 5 years |
| 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 |
| D014694 |
| Ventricular Outflow Obstruction |