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OpenTrials
Completed

NCT Number: NCT00170261

ELIAS: Early Loop-Recorder in Suspected Arrhythmogenic Syncope

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.

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Key information

Conditions

Syncope Consciousness Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Unconsciousness

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Humbold Klinikum, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of an Implantable Loop Recorder

Device

Primary outcomes

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

Secondary outcomes

  1. Cost of diagnostics until final diagnosis has been made

  2. Rate of correct cardiac diagnoses

  3. Comparison of time needed to make a diagnosis

  4. Comparison of pre-syncopes and syncopes occuring in both groups after enrollment

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Collaborators

  • Medtronic

Registry information

Official study title

Early Loop-Recorder in Suspected Arrhythmogenic Syncope

Important dates

Study start
2002
Primary completion
2005
Study completion
2006
First posted
Sep 15, 2005
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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