Bicuspid-related AortopathyPROSPERO-TAVINCT06248294
PRogression Of bicuSPid-rElated aoRtOpathy in Patients Undergoing Transcatheter Aortic Valve Implantation (PROSPERO-TAVI)
An observational study of Bicuspid-related Aortopathy and Aortic Stenosis, run by University of Catania at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bicuspid-related Aortopathy, Aortic Stenosis
- What is being tested?
- CT follow-up
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2024to 1 Jan 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing TAVI for severe aortic stenosis and native bicuspid aortic valve
Who may be able to join
- Patients undergoing TAVI with native BAV from January 2018 to December 2019
Who cannot join
- Patients undergoing TAVI without native BAV
- Patients receiving first generation TAVI device
- Patients undergoing TAVI before January 2018 or after December 2019
Trial locations and contacts
1 site in 1 country.
Italy1 site
AOU Policlinico G. Rodolico - San Marco
Catania, 95123
Giuliano Costa, MD, 393472187329, giulianocosta90@gmail.com
Marco Barbanti, MD, 393283026464, mbarbanti83@gmail.com
About this study
Official title: PRogression Of bicuSPid-rElated aoRtOpathy in Patients Undergoing Transcatheter Aortic Valve Implantation: The PROSPERO-TAVI Multi Center, International Registry
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.
- Conditions
- Bicuspid-related Aortopathy, Aortic Stenosis
- Being tested
- CT follow-up
- Keywords
- BAV, TAVI, Aortopathy
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT follow-upDiagnostic test
Computed tomography angiography assessment of BAV-related aorthopathy
| Study group | Role | What they receive |
|---|---|---|
| TAVI patients with native BAV | Patients undergoing TAVI for severe aortic stenosis and native bicuspid aortic valve Receives: Diagnostic Test: CT follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (3)
Death, stroke or rehospitalization for heart failure
Death, stroke or rehospitalization for heart failure
Measured: 5 years
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.
Measured: 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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Feb 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bicuspid-related AortopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuliano Costa, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248294
- Sponsor's protocol ID
- UCatania003
- Acronym
- PROSPERO-TAVI
- Status last verified
- Jan 2024
- First submitted
- 20 Jan 2024
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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 Oct;300:107494. doi: 10.1016/j.ahj.2026.107494. Epub 2026 May 27.
PubMed 42208924