Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope
NCT ID: NCT02324920
Last Updated: 2021-11-17
Study Results
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View full resultsBasic Information
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COMPLETED
NA
128 participants
INTERVENTIONAL
2015-10-31
2020-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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DDD+CLS
The pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON.
DDD-CLS
ODO
The pacemaker will be programmed in ODO mode.
ODO
Interventions
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DDD-CLS
ODO
Eligibility Criteria
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Inclusion Criteria
* age \>=40 years
* significant limitation of social and working life due to unpredictable or frequent syncope recurrences, ≥2 within the last year.
* type 2B cardio-inhibitory response to TT (according to the VASIS classification).
* Alternative therapies have failed or were not feasible.
* exclusion of other possible competitive causes of syncope.
Exclusion Criteria
Any cardiac dysfunctions possibly leading to loss of consciousness:
* overt heart failure;
* ejection fraction (LVEF) \<40% (Echo-assessed within 3-month prior to study participation);
* myocardial infarction;
* diagnosis of hypertrophic or dilated cardiomyopathy;
* clinically significant valvular disease;
* sinus bradycardia \<50 bpm or sinoatrial block;
* Mobitz I second-degree atrioventricular block;
* Mobitz II second or third-degree atrioventricular block;
* bundle-branch block;
* rapid paroxysmal supraventricular tachycardia or ventricular tachycardia;
* preexcited QRS complexes;
* prolonged QT interval;
* Brugada syndrome;
* arrhythmogenic right ventricular cardiomyopathy
* Symptomatic orthostatic hypotension diagnosed by standing BP measurement;
* Nonsyncopal loss of consciousness (eg, epilepsy, psychiatric, metabolic, drop-attack, cerebral transient ischemic attack, intoxication, cataplexy).
* Symptomatic cardioinhibitory carotid sinus hypersensitivity.
40 Years
ALL
No
Sponsors
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Biotronik SE & Co. KG
INDUSTRY
Responsible Party
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Locations
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CHUS Sherbrooke
Sherbrooke, , Canada
Pais d'Aix
Aix-en-Provence, , France
Hopital de la Timone
Marseille, , France
Clinique Pasteur
Toulouse, , France
Azienda Ospedaliera Pia Fondazione di Culto e Religione Cardinale G. Panico
Tricase, BA, Italy
Policlinico Consorziale
Bari, , Italy
Ospedale Centrale di Bolzano
Bolzano, , Italy
A.O. Pugliese-Ciaccio
Catanzaro, , Italy
Ospedale San Martino
Genova, , Italy
Azienda Ospedaliera Niguarda Ca' Granda
Milan, , Italy
A.O. Dei Colli - Monaldi - University of Campania "Luigi Vanvitelli"
Napoli, , Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
A.O.U. San Luigi Gonzaga
Orbassano, , Italy
AO di Parma
Parma, , Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, , Italy
Policlinico Casilino
Roma, , Italy
AMC Academic Medical Center
Amsterdam, , Netherlands
Rijnstate Ziekenjuis
Arnhem, , Netherlands
Zuyderland Medisch Centrum
Heerlen, , Netherlands
Santa Marta
Lisbon, , Portugal
Hospital De Bellvitge
Barcelona, , Spain
Hospital Universitario Vall d'Hebròn
Barcelona, , Spain
Hospital Universitario Nuestra Senora de la Candelaria
Santa Cruz, , Spain
Hospital Virgen del Rocio
Seville, , Spain
Countries
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References
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Brignole M, Russo V, Arabia F, Oliveira M, Pedrote A, Aerts A, Rapacciuolo A, Boveda S, Deharo JC, Maglia G, Nigro G, Giacopelli D, Gargaro A, Tomaino M; BioSync CLS trial Investigators. Cardiac pacing in severe recurrent reflex syncope and tilt-induced asystole. Eur Heart J. 2021 Feb 1;42(5):508-516. doi: 10.1093/eurheartj/ehaa936.
Brignole M, Tomaino M, Aerts A, Ammirati F, Ayala-Paredes FA, Deharo JC, Del Rosso A, Hamdan MH, Lunati M, Moya A, Gargaro A; BIOSync Study Steering Committee. 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. doi: 10.1186/s13063-017-1941-4.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BA103
Identifier Type: -
Identifier Source: org_study_id