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Size Up Bicuspid with the LIra MEthod: the SUBLIME Study

RECRUITINGSponsored by IRCCS San Raffaele
Actively Recruiting
SponsorIRCCS San Raffaele
Started2024-12-21
Est. completion2025-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06657911

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

Bicuspid Aortic Valve (BAV)Heart Disease

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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