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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

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

Authors: Michele Brignole, Marco Tomaino, Arnaud Aerts, Fabrizio Ammirati, Félix Alejandro Ayala-Paredes, Jean-Claude Deharo, Attilio Del Rosso, Mohamed H. Hamdan, Maurizio Lunati, Angel Moya, Alessio Gargaro, BIOSync Study Steering Committee

Published in: Trials | Issue 1/2017

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Abstract

Background

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.

Trial registration

ClinicalTrials.gov, identifier: NCT02324920 (27 October 2016, date last accessed).
Appendix
Available only for authorised users
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Metadata
Title
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
Authors
Michele Brignole
Marco Tomaino
Arnaud Aerts
Fabrizio Ammirati
Félix Alejandro Ayala-Paredes
Jean-Claude Deharo
Attilio Del Rosso
Mohamed H. Hamdan
Maurizio Lunati
Angel Moya
Alessio Gargaro
BIOSync Study Steering Committee
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-1941-4

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