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

Ritme cardíac; Síncope reflex neurològic; Prova de la taula d’inclinació

Detalles Bibliográficos
Autores: Brignole, Michele, Tomaino, Marco, Aerts, Arnaud, Ammirati, Fabrizio, Ayala-Paredes, Félix, deharo, jean-claude, Moya Mitjans, Angel
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2017
País:España
Institución:Departament de Salut de la Generalitat de Catalunya (DS)
Repositorio:Scientia. Dipòsit d'Informació Digital del Departament de Salut
OAI Identifier:oai:scientiasalut.gencat.cat:11351/5892
Acceso en línea:https://hdl.handle.net/11351/5892
Access Level:acceso abierto
Palabra clave:Síncope (Patologia)
Cor - Batecs
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Diagnostic Techniques and Procedures::Diagnostic Techniques, Cardiovascular::Tilt-Table Test
DISEASES::Nervous System Diseases::Autonomic Nervous System Diseases::Primary Dysautonomias::Orthostatic Intolerance::Syncope, Vasovagal
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::técnicas y procedimientos diagnósticos::técnicas diagnósticas cardiovasculares::prueba de mesa basculante
ENFERMEDADES::enfermedades del sistema nervioso::enfermedades del sistema nervioso autónomo::disautonomías primarias::intolerancia ortostática::síncope vasovagal
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oai_identifier_str oai:scientiasalut.gencat.cat:11351/5892
network_acronym_str ES
network_name_str España
repository_id_str
dc.title.none.fl_str_mv 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
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
spellingShingle 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
Brignole, Michele
Síncope (Patologia)
Cor - Batecs
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Diagnostic Techniques and Procedures::Diagnostic Techniques, Cardiovascular::Tilt-Table Test
DISEASES::Nervous System Diseases::Autonomic Nervous System Diseases::Primary Dysautonomias::Orthostatic Intolerance::Syncope, Vasovagal
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::técnicas y procedimientos diagnósticos::técnicas diagnósticas cardiovasculares::prueba de mesa basculante
ENFERMEDADES::enfermedades del sistema nervioso::enfermedades del sistema nervioso autónomo::disautonomías primarias::intolerancia ortostática::síncope vasovagal
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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
dc.creator.none.fl_str_mv Brignole, Michele
Tomaino, Marco
Aerts, Arnaud
Ammirati, Fabrizio
Ayala-Paredes, Félix
deharo, jean-claude
Moya Mitjans, Angel
author Brignole, Michele
author_facet Brignole, Michele
Tomaino, Marco
Aerts, Arnaud
Ammirati, Fabrizio
Ayala-Paredes, Félix
deharo, jean-claude
Moya Mitjans, Angel
author_role author
author2 Tomaino, Marco
Aerts, Arnaud
Ammirati, Fabrizio
Ayala-Paredes, Félix
deharo, jean-claude
Moya Mitjans, Angel
author2_role author
author
author
author
author
author
dc.contributor.none.fl_str_mv Institut Català de la Salut
[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
Vall d'Hebron Barcelona Hospital Campus
dc.subject.none.fl_str_mv Síncope (Patologia)
Cor - Batecs
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Diagnostic Techniques and Procedures::Diagnostic Techniques, Cardiovascular::Tilt-Table Test
DISEASES::Nervous System Diseases::Autonomic Nervous System Diseases::Primary Dysautonomias::Orthostatic Intolerance::Syncope, Vasovagal
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::técnicas y procedimientos diagnósticos::técnicas diagnósticas cardiovasculares::prueba de mesa basculante
ENFERMEDADES::enfermedades del sistema nervioso::enfermedades del sistema nervioso autónomo::disautonomías primarias::intolerancia ortostática::síncope vasovagal
topic Síncope (Patologia)
Cor - Batecs
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Diagnostic Techniques and Procedures::Diagnostic Techniques, Cardiovascular::Tilt-Table Test
DISEASES::Nervous System Diseases::Autonomic Nervous System Diseases::Primary Dysautonomias::Orthostatic Intolerance::Syncope, Vasovagal
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::técnicas y procedimientos diagnósticos::técnicas diagnósticas cardiovasculares::prueba de mesa basculante
ENFERMEDADES::enfermedades del sistema nervioso::enfermedades del sistema nervioso autónomo::disautonomías primarias::intolerancia ortostática::síncope vasovagal
description Ritme cardíac; Síncope reflex neurològic; Prova de la taula d’inclinació
publishDate 2017
dc.date.none.fl_str_mv 2017
2021
2021
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/11351/5892
url https://hdl.handle.net/11351/5892
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Trials;18(1)
http://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-1941-4
dc.rights.none.fl_str_mv Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv BMC
publisher.none.fl_str_mv BMC
dc.source.none.fl_str_mv Scientia
reponame:Scientia. Dipòsit d'Informació Digital del Departament de Salut
instname:Departament de Salut de la Generalitat de Catalunya (DS)
instname_str Departament de Salut de la Generalitat de Catalunya (DS)
reponame_str Scientia. Dipòsit d'Informació Digital del Departament de Salut
collection Scientia. Dipòsit d'Informació Digital del Departament de Salut
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869423293496295424
spelling Benefit of dual-chamber pacing with Closed Loop Stimulation in tilt-induced cardio-inhibitory reflex syncope (BIOSync trial): study protocol for a randomized controlled trialBrignole, MicheleTomaino, MarcoAerts, ArnaudAmmirati, FabrizioAyala-Paredes, Félixdeharo, jean-claudeMoya Mitjans, AngelSíncope (Patologia)Cor - BatecsANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Diagnostic Techniques and Procedures::Diagnostic Techniques, Cardiovascular::Tilt-Table TestDISEASES::Nervous System Diseases::Autonomic Nervous System Diseases::Primary Dysautonomias::Orthostatic Intolerance::Syncope, VasovagalTÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::técnicas y procedimientos diagnósticos::técnicas diagnósticas cardiovasculares::prueba de mesa basculanteENFERMEDADES::enfermedades del sistema nervioso::enfermedades del sistema nervioso autónomo::disautonomías primarias::intolerancia ortostática::síncope vasovagalRitme cardíac; Síncope reflex neurològic; Prova de la taula d’inclinacióRitmo cardíaco; Síncope reflejo neuromediado; Prueba de la mesa inclinadaCardiac pacing; Neuro-mediated reflex syncope; Tilt-Table testBackground: 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.All study-related costs are being directly supported by the sponsor of the study (BIOTRONIK SE & Co. KG, Berlin, Germany). No further funding is provided.BMCInstitut Català de la Salut[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, SpainVall d'Hebron Barcelona Hospital Campus202120212017info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/11351/5892Scientiareponame:Scientia. Dipòsit d'Informació Digital del Departament de Salutinstname:Departament de Salut de la Generalitat de Catalunya (DS)InglésTrials;18(1)http://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-1941-4Attribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:scientiasalut.gencat.cat:11351/58922026-06-12T09:38:37Z
score 15.812429

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