CompletedPhase 4

ELIAS: Early Loop-Recorder in Suspected Arrhythmogenic Syncope

Germany100 participantsStarted 2002-04

Plain-language summary

This is a prospective, controlled, opened randomized study to evaluate the cost benefit of a primary implantation of a loop recorder versus the conventional diagnostic cascade for syncope most likely due to cardiac arrhythmia.

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Two or more episodes of syncope (most likely due to cardiac arrhythmia) of uncertain etiology within the last 12 months or more than one syncope and two presyncopes Exclusion Criteria: * Indication for the implantation of a pacemaker * Indication for the implantation of an implantable cardioverter defibrillator * Cardiac diseases which need intervention (KHK, aortic stenosis, mitral stenosis, left ventricular \[LV\] outflow stenosis, decompensated heart failure) * Contraindication for a diagnostic procedure requested by the study protocol * Enrollment in another study * Circumstances or comorbidities which do not allow enrollment

What they're measuring

Cost of diagnostics per patient until final cardiac diagnosis has been made

Trial details

NCT IDNCT00170261

SponsorMedtronic Cardiac Rhythm and Heart Failure

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2005-09

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