Size Up Bicuspid With the LIra MEthod: the SUBLIME Study
ConditionBicuspid Aortic Valve (BAV)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Redo-TAVR
TAVR performed in emergency setting
TAVR performed for severe aortic regurgitation
Trial design
Treatments tested in this trial
- Not listed
Trial groups
250 Participants
are grouped into 1 trial groupSponsors and collaborators
Source ClinicalTrials.gov