Journal Article

International study on syncope of uncertain aetiology 3 (ISSUE 3): pacemaker therapy for patients with asystolic neurally-mediated syncope: rationale and study design

in EP Europace

Published on behalf of European Heart Rhythm Association of the European Society of Cardiology (ESC)

Volume 9, issue 1, pages 25-30
Published in print January 2007 | ISSN: 1099-5129
Published online January 2007 | e-ISSN: 1532-2092 | DOI: http://dx.doi.org/10.1093/europace/eul135
International study on syncope of uncertain aetiology 3 (ISSUE 3): pacemaker therapy for patients with asystolic neurally-mediated syncope: rationale and study design

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Aim To assess the effectiveness of pacing therapy for preventing syncope recurrence in patients with a high probability of cardio-inhibitory neurally-mediated syncope (NMS).

Methods Study design: Multi-centre, prospective, double-blind, randomized placebo-controlled study. Inclusion criteria: Eligible patients are at least 40 years of age and have suffered, in the prior 2 years, ≥ 3 syncope episodes of suspected NMS (with the exception of carotid sinus syndrome), which is considered by the attending physician to have a severe clinical presentation requiring treatment initiation. Patients with positive and negative tilt testing are included. Exclusion criteria: Patients with one or more of the following are excluded: carotid sinus syndrome; suspected or definite heart disease and high likelihood of cardiac syncope; symptomatic orthostatic hypotension diagnosed by standing blood pressure measurement; loss of consciousness different from syncope (e.g. epilepsy, psychiatric, metabolic, drop-attack, TIA, intoxication, cataplexy); subclavian steal syndrome. Study protocol: Eligible patients receive an Implantable Loop Recorder and are followed till the first documented syncopal recurrence or a significant asystolic event. Those patients who have an asystolic pause (sinus arrest or AV block) > 6 s or a syncopal asystolic pause ≥ 3 s receive a dual-chamber pacemaker implantation and are randomized to active therapy (Pm ON) or to placebo therapy (Pm OFF). End-points: Primary end-point is the first syncope recurrence after pacemaker implant. Sample size and duration: A maximum of 710 patients are to be enrolled during an anticipated period of 2 years to allow randomization of 60 patients in the Pm ON arm and 60 in the Pm OFF arm (total 120).

Keywords: Syncope; Neurally-mediated syncope; Pacemaker therapy; Electrocardiographic monitoring; Implantable loop recorder

Journal Article.  3558 words.  Illustrated.

Subjects: Cardiovascular Medicine

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