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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRogression Of bicuSPid-rElated aoRtOpathy in Patients Undergoing Transcatheter Aortic Valve Implantation: The PROSPERO-TAVI Multi Center, International Registry
- ClinicalTrials.gov ID
- NCT06248294
- Acronym / sponsor ID
- PROSPERO-TAVI / UCatania003
- Conditions
- Bicuspid-related Aortopathy, Aortic Stenosis
- Keywords
- BAV, TAVI, Aortopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAVI patients with native BAV | – | Diagnostic Test: CT follow-upPatients undergoing TAVI for severe aortic stenosis and native bicuspid aortic valve |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing TAVI for severe aortic stenosis and native bicuspid aortic valve
Key inclusion criteria (1 listed)
- Patients undergoing TAVI with native BAV from January 2018 to December 2019
Key exclusion criteria (3 listed)
- Patients undergoing TAVI without native BAV
- Patients receiving first generation TAVI device
- Patients undergoing TAVI before January 2018 or after December 2019
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT follow-upComputed tomography angiography assessment of BAV-related aorthopathy | Diagnostic test | TAVI patients with native BAV |
Primary outcome
Absolute difference in maximum aortic diameters at multiple levels of ascending aorta
Time frame: 5 years
Measurements of maximum aortic diameters at follow-up CTA assessment will be compared with values at pre-TAVI CTA assessment
3 secondary outcomes
Death, stroke or rehospitalization for heart failure
Time frame: 5 years
Aortic events leading to urgent intervention or elective aortic root replacement
Time frame: 5 years
Bioprosthesis dysfunction (HALT or RLM at 4-D CTA assessment)
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Derived from this study: PubMed 42208924Costa 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bicuspid-related Aortopathy and Aortic Stenosis, run by University of Catania at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuliano Costa, MD (3934721874329, giulianocosta90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute difference in maximum aortic diameters at multiple levels of ascending aorta (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06248294, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.