Actively Recruiting
Size Up Bicuspid With the LIra MEthod: the SUBLIME Study
Led by IRCCS San Raffaele · Updated on 2025-01-03
250
Participants Needed
5
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Transcatheter aortic valve replacement (TAVR) outcomes in patients with raphe-type bicuspid aortic valve (BAV) are still suboptimal for the non negligible rate of stroke and permanent pacemaker implantation. There is still lack of consensus on the optimal sizing method for prosthesis selection in BAV patients. The objective of the present study is to evaluate the efficacy and safety of the LIRA sizing method in raphe-type BAV patients undergoing TAVR.
CONDITIONS
Official Title
Size Up Bicuspid With the LIra MEthod: the SUBLIME Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years old with severe aortic stenosis
- Diagnosis of type 1 or type 2 bicuspid aortic valve according to Sievers classification
- Undergoing TAVR with self-expanding supra-annular prostheses sized using the LIRA method
- TAVR performed between September 2018 and June 2024
You will not qualify if you...
- Previous TAVR procedure (Redo-TAVR)
- TAVR performed in an emergency setting
- TAVR performed for severe aortic regurgitation instead of stenosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Fondazione Poliambulanza
Brescia, Italy, Italy, 25100
Actively Recruiting
2
Spedali Civili
Brescia, Italy, Italy, 25100
Actively Recruiting
3
Ospedale San Donato
Milan, Italy, Italy, 20100
Actively Recruiting
4
San Camillo Hospital
Roma, Italy, Italy, 00100
Actively Recruiting
5
Luzerner Kantonsspital
Lucerne, Switzerland, Switzerland, 6009
Actively Recruiting
Research Team
P
Prof. Matteo Montorfano, MD
CONTACT
B
Barbara Bellini, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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