ELIAS: Early Loop-Recorder in Suspected Arrhythmogenic Syncope

Last updated: June 30, 2025
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Overall Status: Completed

Phase

4

Condition

Cataplexy

Low Blood Pressure (Hypotension)

Dizzy/fainting Spells

Treatment

Use of an Implantable Loop Recorder

Clinical Study ID

NCT00170261
CEN_G_CA_4
  • Ages 18-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Two or more episodes of syncope (most likely due to cardiac arrhythmia) of uncertainetiology within the last 12 months or more than one syncope and two presyncopes

Exclusion

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

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Use of an Implantable Loop Recorder
Phase: 4
Study Start date:
April 01, 2002
Estimated Completion Date:
September 30, 2006

Connect with a study center

  • Humbold Klinikum

    Berlin, 13509
    Germany

    Site Not Available

  • Vivantes Klinikum am Urban

    Berlin, 10967
    Germany

    Site Not Available

  • Universitätsklinikum Hamburg Eppendorf

    Hamburg, 20251
    Germany

    Site Not Available

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