Size Up Bicuspid with the LIra MEthod: the SUBLIME Study
NCT ID: NCT06657911
Last Updated: 2025-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
250 participants
OBSERVATIONAL
2024-12-21
2026-04-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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OTHER
OTHER
Study Groups
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BAV patients underoging TAVR
Patients with bicuspid aortic valve undergoing TAVI for severe aortic stenosis with sizing performed
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* TAVR performed in emergency setting
* TAVR performed for severe aortic regurgitation
18 Years
ALL
No
Sponsors
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IRCCS San Raffaele
OTHER
Responsible Party
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Matteo Montorfano
Professor, cardiologist
Principal Investigators
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Prof. Matteo Montorfano, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS San Raffaele Scientific Institute
Locations
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Fondazione Poliambulanza
Brescia, Italy, Italy
Spedali Civili
Brescia, Italy, Italy
Ospedale San Donato
Milan, Italy, Italy
San Camillo Hospital
Roma, Italy, Italy
Luzerner Kantonsspital
Lucerne, Switzerland, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Andrea Buono, MD
Role: primary
Mauro Massussi, MD
Role: primary
Riccardo Gorla, MD
Role: primary
Francesco DE Felice MD
Role: primary
Stefan Toggweiler, MD
Role: primary
References
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Hayashida K, Bouvier E, Lefevre T, Chevalier B, Hovasse T, Romano M, Garot P, Watanabe Y, Farge A, Donzeau-Gouge P, Cormier B, Morice MC. Transcatheter aortic valve implantation for patients with severe bicuspid aortic valve stenosis. Circ Cardiovasc Interv. 2013 Jun;6(3):284-91. doi: 10.1161/CIRCINTERVENTIONS.112.000084. Epub 2013 Jun 11.
Bauer T, Linke A, Sievert H, Kahlert P, Hambrecht R, Nickenig G, Hauptmann KE, Sack S, Gerckens U, Schneider S, Zeymer U, Zahn R. Comparison of the effectiveness of transcatheter aortic valve implantation in patients with stenotic bicuspid versus tricuspid aortic valves (from the German TAVI Registry). Am J Cardiol. 2014 Feb 1;113(3):518-21. doi: 10.1016/j.amjcard.2013.10.023. Epub 2013 Nov 9.
Perlman GY, Blanke P, Dvir D, Pache G, Modine T, Barbanti M, Holy EW, Treede H, Ruile P, Neumann FJ, Gandolfo C, Saia F, Tamburino C, Mak G, Thompson C, Wood D, Leipsic J, Webb JG. Bicuspid Aortic Valve Stenosis: Favorable Early Outcomes With a Next-Generation Transcatheter Heart Valve in a Multicenter Study. JACC Cardiovasc Interv. 2016 Apr 25;9(8):817-824. doi: 10.1016/j.jcin.2016.01.002.
Yoon SH, Lefevre T, Ahn JM, Perlman GY, Dvir D, Latib A, Barbanti M, Deuschl F, De Backer O, Blanke P, Modine T, Pache G, Neumann FJ, Ruile P, Arai T, Ohno Y, Kaneko H, Tay E, Schofer N, Holy EW, Luk NHV, Yong G, Lu Q, Kong WKF, Hon J, Kao HL, Lee M, Yin WH, Park DW, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Kim HS, Butter C, Khalique OK, Schaefer U, Nietlispach F, Kodali SK, Leon MB, Ye J, Chevalier B, Leipsic J, Delgado V, Bax JJ, Tamburino C, Colombo A, Sondergaard L, Webb JG, Park SJ. Transcatheter Aortic Valve Replacement With Early- and New-Generation Devices in Bicuspid Aortic Valve Stenosis. J Am Coll Cardiol. 2016 Sep 13;68(11):1195-1205. doi: 10.1016/j.jacc.2016.06.041.
Iannopollo G, Romano V, Buzzatti N, De Backer O, Sondergaard L, Merkely B, Prendergast BD, Giannini F, Colombo A, Latib A, Granada JF, Chieffo A, Montorfano M. A novel supra-annular plane to predict TAVI prosthesis anchoring in raphe-type bicuspid aortic valve disease: the LIRA plane. EuroIntervention. 2020 Jun 25;16(3):259-261. doi: 10.4244/EIJ-D-19-00951. No abstract available.
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.
Iannopollo G, Romano V, Esposito A, Guazzoni G, Ancona M, Ferri L, Russo F, Bellini B, Buzzatti N, Curio J, Prendergast B, Montorfano M. Update on supra-annular sizing of transcatheter aortic valve prostheses in raphe-type bicuspid aortic valve disease according to the LIRA method. Eur Heart J Suppl. 2022 May 18;24(Suppl C):C233-C242. doi: 10.1093/eurheartj/suac014. eCollection 2022 May.
Other Identifiers
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SUBLIME
Identifier Type: -
Identifier Source: org_study_id
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