RecruitingNCT06657911

Size Up Bicuspid With the LIra MEthod: the SUBLIME Study

SUBLIME: Size Up Bicuspid With the LIra MEthod: the SUBLIME Study


Sponsor

IRCCS San Raffaele

Enrollment

250 participants

Start Date

Dec 21, 2024

Study Type

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

Min Age: 18 Years

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)

Fondazione Poliambulanza

Brescia, Italy, Italy

Spedali Civili

Brescia, Italy, Italy

Ospedale San Donato

Milan, Italy, Italy

San Camillo Hospital

Roma, Italy, Italy

Luzerner Kantonsspital

Lucerne, Switzerland, Switzerland

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NCT06657911


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