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Size Up Bicuspid With the LIra MEthod: the SUBLIME Study

Recruitingn/aAges 18 Years - anyAllIRCCS San Raffaele
NCT06657911 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

5 sites
Fondazione Poliambulanza
Brescia, Italy
Spedali Civili
Brescia, Italy
Ospedale San Donato
Milan, Italy
San Camillo Hospital
Roma, Italy
Luzerner Kantonsspital
Lucerne, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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