Evaluating the LIRA method for sizing in patients with bicuspid aortic valves
SUBLIME: Size Up Bicuspid With the LIra MEthod: the SUBLIME Study
IRCCS San Raffaele · NCT06657911
This study is testing a new sizing method for heart valve replacement in adults with a specific type of heart valve problem to see if it can make the procedure safer and more effective.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele (other) |
| Locations | 5 sites (Brescia, Italy and 4 other locations) |
| Trial ID | NCT06657911 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy and safety of the LIRA sizing method for transcatheter aortic valve replacement (TAVR) in patients with raphe-type bicuspid aortic valves (BAV). The study will include patients over 18 years old with severe aortic stenosis and specific types of BAV who undergo TAVR with self-expanding supra-annular prostheses sized according to the LIRA method. The research addresses the challenges faced in treating BAV patients, particularly the high rates of complications associated with traditional sizing methods. By focusing on the unique anatomy of BAV, the study seeks to improve patient outcomes in this population.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with severe aortic stenosis and type 1 or 2 bicuspid aortic valves undergoing TAVR.
Not a fit: Patients who have undergone redo-TAVR, emergency TAVR, or TAVR for severe aortic regurgitation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved TAVR outcomes and reduced complications for patients with bicuspid aortic valves.
How similar studies have performed: While there is limited data on the LIRA method specifically, recent evidence suggests that alternative sizing methods may improve outcomes in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients over 18 years old with severe aortic stenosis and type 1 or 2 BAV according to Sievers classification) undergone TAVR with self-expanding supra-annular prostheses sized according to the LIRA method between September 2018 and June 2024 Exclusion Criteria: * Redo-TAVR * TAVR performed in emergency setting * TAVR performed for severe aortic regurgitation
Where this trial is running
Brescia, Italy and 4 other locations
- Fondazione Poliambulanza — Brescia, Italy, Italy (RECRUITING)
- Spedali Civili — Brescia, Italy, Italy (RECRUITING)
- Ospedale San Donato — Milan, Italy, Italy (RECRUITING)
- San Camillo Hospital — Roma, Italy, Italy (RECRUITING)
- Luzerner Kantonsspital — Lucerne, Switzerland, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Prof. Matteo Montorfano, MD — IRCCS San Raffaele Scientific Institute
- Study coordinator: Prof. Matteo Montorfano, MD
- Email: montorfano.matteo@hsr.it
- Phone: 0039/02/26437331
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bicuspid Aortic Valve, LIRA method, Bicuspid aortic Valve, TAVR