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Recruiting NCT06657911

Size Up Bicuspid With the LIra MEthod: the SUBLIME Study

— Observational Bicuspid Aortic Valve (BAV)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Bicuspid Aortic Valve (BAV). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy, Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

SUBLIME: Size Up Bicuspid With the LIra MEthod: the SUBLIME Study

Overview

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.

Primary outcome measures

  • Device success [Time frame: Up to 30 days after TAVI procedure]
Secondary outcome measures (4)
  • Number of partecipants with TAVI-related Adverse Events as assessed by VARC 3 criteria. [Time frame: Up to 30 days after TAVI procedure]
  • Clinical efficacy [Time frame: Up to 1 year after TAVI procedure]
  • Technical success [Time frame: At exit from procedure room]
  • Intended performance of the valve [Time frame: Up to 30 days after TAVI procedure]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Italy · 4 centers
  • Fondazione Poliambulanza — Brescia
  • Spedali Civili — Brescia
  • Ospedale San Donato — Milan
  • San Camillo Hospital — Roma
Switzerland · 1 center
  • Luzerner Kantonsspital — Lucerne

Publications

  • 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. PMID 23756698
  • 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. PMID 24342758
  • 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. PMID 27101906
  • 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, Cheval PMID 27609682
  • 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. PMID 31659989
  • 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. PMID 32473284
  • 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. PMID 35602251

Identifiers

NCT: NCT06657911 · SUBLIME

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗