Size Up Bicuspid With the LIra MEthod: the SUBLIME Study
SUBLIME: Size Up Bicuspid With the LIra MEthod: the SUBLIME Study
IRCCS San Raffaele
250 participants
Dec 21, 2024
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria1
- 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 Criteria3
- Redo-TAVR
- TAVR performed in emergency setting
- TAVR performed for severe aortic regurgitation
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Locations(5)
View Full Details on ClinicalTrials.gov
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NCT06657911