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Clinical Trials in Italy / NCT06657911
Recruiting Observational

Size Up Bicuspid With the LIra MEthod: the SUBLIME Study

NCT06657911 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS San Raffaele
Phase
Observational
Started
2024-12-21
Last updated
2025-01-03

Condition(s) studied

Bicuspid Aortic Valve (BAV)

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * Redo-TAVR * TAVR performed in emergency setting * TAVR performed for severe aortic regurgitation

Primary outcome measure(s)

  • Device success — Up to 30 days after TAVI procedure
    Device success as defined by VARC 3 criteria : presence of technical success, freedom from mortality, freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complications, intended performance of the valve (less than moderate aortic regurgitation, mean gradient \< 20 mmHg, peak velocity \<3 m/s, doppler velocity index \>0.25).

Trial sites (5)

FacilityCityRegionStatus
Fondazione Poliambulanza Brescia Italy Recruiting
Spedali Civili Brescia Italy Recruiting
Ospedale San Donato Milan Italy Recruiting
San Camillo Hospital Roma Italy Recruiting
Luzerner Kantonsspital Lucerne Switzerland Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06657911 on ClinicalTrials.gov ↗ ← All trials in Italy