Size Up Bicuspid with the LIra MEthod: the SUBLIME Study

Recruiting

• Conditions: Bicuspid Aortic Valve (BAV)

• Registration Number: NCT06657911
• Lead Sponsor: IRCCS San Raffaele

Brief 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.

Study Timeline

• Study First Submitted: 2024-09-24
• Study First Submitted QC: 2024-10-23
• Study First Posted: 2024-10-26
• Study Start: 2024-12-21
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Primary Completion: 2025-12-31
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
Number of partecipants with TAVI-related Adverse Events as assessed by VARC 3 criteria.	Up to 30 days after TAVI procedure	* All-cause mortality; * All stroke; * VARC type 2-4 bleeding; * Major vascular, access-related, or cardiac structural complication; * Acute kidney injury stage 3 or 4; * New permanent pacemaker due to procedure- related conduction abnormalities; * Surgery or intervention related to the device
Clinical efficacy	Up to 1 year after TAVI procedure	Freedom from all-cause mortality, freedom from all stroke, freedom from hospitalization for procedure -or-valve-related causes, freedom from KCCQ Overall Summary score \<45 or decline from baseline \>10 point
Technical success	At exit from procedure room	Freedom from mortality; successful access, delivery and retrieval of the delivery system; correct positioning of a single prosthetic heart valve into the proper anatomical location; freedom from surgey or intervention related to the device or to a major vascular or access-related, or cardiac structural.
Intended performance of the valve	Up to 30 days after TAVI procedure	Less than moderate aortic regurgitation, mean gradient \< 20 mmHg, peak velocity \<3 m/s, doppler velocity index \>0.25

Trial Locations

Locations (5)

Fondazione Poliambulanza; 🇮🇹 Brescia, Italy

Spedali Civili; 🇮🇹 Brescia, Italy

Ospedale San Donato; 🇮🇹 Milan, Italy

San Camillo Hospital; 🇮🇹 Roma, Italy

Luzerner Kantonsspital; 🇨🇭 Luzern, Switzerland