SUBLIME: Size Up Bicuspid with the LIra MEthod: the SUBLIME Study
Status: Recruiting
Location: See all (5) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Italy
Fondazione Poliambulanza
RECRUITING
Brescia
Spedali Civili
RECRUITING
Brescia
Ospedale San Donato
RECRUITING
Milan
San Camillo Hospital
RECRUITING
Roma
Switzerland
Luzerner Kantonsspital
RECRUITING
Lucerne
Contact Information
Primary
Prof. Matteo Montorfano, MD
montorfano.matteo@hsr.it
0039/02/26437331
Backup
Barbara Bellini, MD
bellini.barbara@hsr.it
0039/02/26437331
Time Frame
Start Date: 2024-12-21
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 250
Treatments
BAV patients underoging TAVR
Patients with bicuspid aortic valve undergoing TAVI for severe aortic stenosis with sizing performed
Related Therapeutic Areas
Sponsors
Leads: IRCCS San Raffaele