Show simple item record

 
dc.contributorVall d'Hebron Barcelona Hospital Campus
dc.contributor.authorBrignole, Michele
dc.contributor.authorTomaino, Marco
dc.contributor.authorAerts, Arnaud
dc.contributor.authorAmmirati, Fabrizio
dc.contributor.authorAyala-Paredes, Félix Alejandro
dc.contributor.authorDeharo, Jean-Claude
dc.contributor.authorMoya Mitjans, Angel
dc.date.accessioned2021-04-22T07:49:21Z
dc.date.available2021-04-22T07:49:21Z
dc.date.issued2017-05-04
dc.identifier.citationBrignole M, Tomaino M, Aerts A, Ammirati F, Ayala-Parades FA, Deharo JC, et al. Benefit of dual-chamber pacing with Closed Loop Stimulation in tilt-induced cardio-inhibitory reflex syncope (BIOSync trial): Study protocol for a randomized controlled trial. Trials. 2017 May 4;18(1):208.
dc.identifier.issn1745-6215
dc.identifier.urihttp://hdl.handle.net/11351/5892
dc.descriptionCardiac pacing; Neuro-mediated reflex syncope; Tilt-Table test
dc.description.abstractBackground: The efficacy of dual-chamber cardiac pacing in neuro-mediated reflex syncope with a cardio-inhibitory response to the Tilt-Table test (TT) has not been definitively assessed so far. The lack of reproducibility of results from previous studies may be partially explained by discrepancies in subject selection and some weaknesses in design and methods. The European Society of Cardiology (ESC) has set a class IIb indication to pacemaker implantation in this population recommending further research. Methods/design: The BIOSync study is a multicenter, patient- and outcome-assessor-blind, randomized, parallel-arm, placebo-controlled trial with the objective of assessing the clinical benefit of cardiac pacing in patients with frequently recurrent reflex syncope, suspected (but not proven) to be triggered by asystolic pauses as showing a VASIS 2B response to the TT (>3-s pause regardless of blood pressure drop). The primary and secondary endpoints are time to first post-implantation recurrence of syncope or the combination of pre-syncope or syncope, respectively. One hundred and twenty-eight consenting patients will be 1:1 randomized to dual-chamber cardiac pacing 'on' or 'off' after pacemaker implantation, and followed up until the first adjudicated primary endpoint event for a maximum of 2 years. The so-called Closed Loop Stimulation function on top of dual-chamber pacing is the pacing mode selected in the study active arm. Participating patients are asked to self-report syncopal symptoms at least every 3 months with self-administered questionnaires addressed to an independent Adjudication Committee. Patients and members of the Adjudicating Committee are blinded to randomization. The study is designed to detect a 40% relative reduction in the 2-year incidence of syncopal recurrences with 80% statistical power. Discussion: The BIOSync study is designed to definitively assess the benefit of pacing against placebo in reflex syncope patients with a cardio-inhibitory response to the TT. The study will also provide important information on the efficiency of the TT in appropriately selecting reflex syncope patients for cardiac pacing.
dc.language.isoeng
dc.publisherBMC
dc.relation.ispartofseriesTrials;18(1)
dc.rightsAttribution 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.sourceScientia
dc.subjectSíncope (Patologia)
dc.subjectCor - Batecs
dc.subject.meshTilt-Table Test
dc.subject.meshSyncope, Vasovagal
dc.titleBenefit of dual-chamber pacing with Closed Loop Stimulation in tilt-induced cardio-inhibitory reflex syncope (BIOSync trial): study protocol for a randomized controlled trial
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1186/s13063-017-1941-4
dc.subject.decsprueba de mesa basculante
dc.subject.decssíncope vasovagal
dc.relation.publishversionhttp://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-1941-4
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dc.audienceProfessionals
dc.contributor.organismesInstitut Català de la Salut
dc.contributor.authoraffiliation[Brignole M] Ospedali del Tigullio, Arrhythmologic Centre, Department of Cardiology, Via Don Bobbio, 25, 16033 Lavagna, GE, Italy. [Tomaino M] Central Hospital, Bolzano, Italy. [Aerts A] Atrium MC, Heerlen, Netherlands. [Ammirati F] G.B. Grassi Hospital, Rome, Italy. [Ayala-Paredes FA] CHUS – Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada. [Deharo JC] la Timone University Hospital, Marseille, France. [Moya A] Vall d’Hebron Hospital Universitari, Barcelona, Spain
dc.identifier.pmid28472974
dc.identifier.wos000401373200001
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess


Files in this item

Thumbnail

This item appears in the following Collection(s)

Show simple item record