Clinical trial NCT06657911: Size Up Bicuspid with the LIra MEthod: the SUBLIME Study
Official title: SUBLIME: Size Up Bicuspid with the LIra MEthod: the SUBLIME Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bicuspid Aortic Valve (BAV)
Keywords: LIRA method
Bicuspid aortic Valve
TAVR
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients over 18 years old with severe aortic stenosis and type 1 or 2 BAV undergone TAVR with self-expanding supra-annular prostheses sized according to the LIRA method

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.

Eligibility criteria: 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 outcomes:
measure: Device success
timeFrame: Up to 30 days after TAVI procedure
Secondary outcomes:
measure: Number of partecipants with TAVI-related Adverse Events as assessed by VARC 3 criteria.
timeFrame: Up to 30 days after TAVI procedure
measure: Clinical efficacy
timeFrame: Up to 1 year after TAVI procedure
measure: Technical success
timeFrame: At exit from procedure room
measure: Intended performance of the valve
timeFrame: Up to 30 days after TAVI procedure
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Fondazione Poliambulanza
city: Brescia
country: Italy
facility: Spedali Civili
city: Milan
country: Italy
facility: Ospedale San Donato
city: Roma
country: Italy
facility: San Camillo Hospital
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
Study officials:
affiliation: IRCCS San Raffaele Scientific Institute
name: Prof. Matteo Montorfano, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Iannopollo G, Romano V, Buzzatti N, Ancona M, Ferri L, Russo F, Bellini B, Granada JF, Chieffo A, Montorfano M. Supra-annular sizing of transcatheter aortic valve prostheses in raphe-type bicuspid aortic valve disease: the LIRA method. Int J Cardiol. 2020 Oct 15;317:144-151. doi: 10.1016/j.ijcard.2020.05.076. Epub 2020 May 28.
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