MedTrace Logo

Size Up Bicuspid with the LIra MEthod: the SUBLIME Study

NCT06657911 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2025-01-03

No results posted yet for this study

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.

Conditions

  • Bicuspid Aortic Valve (BAV)

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • Prof. Matteo Montorfano, MD · IRCCS San Raffaele Scientific Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-21
Primary Completion
2025-12-31
Completion
2026-04-30

Countries

  • Italy
  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06657911 on ClinicalTrials.gov