NCT06657911

Size Up Bicuspid With the LIra MEthod: the SUBLIME Study

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Bicuspid aortic valve (BAV) still represents a challenge for percutaneous treatment due to the peculiar anatomy. BAV patients have been historically excluded from major randomized controlled trials. Observational data have showed a high rate of paravalvular leak (PVL) with the use of self-expanding prostheses and a non-negligible rate of annular rupture with the use of balloon expandable valves. More recent data have shown better outcomes with current generation prostheses although the rate of stroke and permanent pacemaker implantation remains high. These suboptimal results, possibly related to BAV different anatomy, have advocated the use of different sizing method for prosthesis selection in this setting. Recent evidence has shown that transcatheter heart valve (THV) anchoring in BAV patients might occur at the raphe-level, defined as the LIRA (Level of Implantation at the RAphe) plane. Thus, a novel supra-annular sizing method based on the measurement of the perimeter at the raphe-level, the LIRA-method, has been developed in our center and validated in small cohorts of patients. The aim of our study is to evaluate the efficacy and safety of the LIRA method in raphe-type bicuspid patients undergoing TAVR.

Conditions

• Bicuspid Aortic Valve (BAV)

Timeline

• Start date: 2024-12-21
• Primary completion: 2025-12-31
• Completion: 2026-04-30
• First posted: 2024-10-26
• Last updated: 2025-01-03

Locations

5 sites across 2 countries: Italy, Switzerland