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RECRUITING
NCT06657911

Size Up Bicuspid With the LIra MEthod: the SUBLIME Study

Sponsor: IRCCS San Raffaele

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

250

Start Date

2024-12-21

Completion Date

2026-04-30

Last Updated

2025-01-03

Healthy Volunteers

No

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