ELIAS: Early Loop-Recorder in Suspected Arrhythmogenic Syncope

This study has been completed.
Information provided by:
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
First received: September 12, 2005
Last updated: October 8, 2008
Last verified: October 2008

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.

Condition Intervention Phase
Device: Use of an Implantable Loop Recorder
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Early Loop-Recorder in Suspected Arrhythmogenic Syncope

Resource links provided by NLM:

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • Cost of diagnostics per patient until final cardiac diagnosis has been made

Secondary Outcome Measures:
  • Cost of diagnostics until final diagnosis has been made
  • Rate of correct cardiac diagnoses
  • Comparison of time needed to make a diagnosis
  • Comparison of pre-syncopes and syncopes occuring in both groups after enrollment

Estimated Enrollment: 100
Study Start Date: April 2002
Study Completion Date: September 2006
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00170261

Vivantes Klinikum am Urban
Berlin, Germany, 10967
Humbold Klinikum
Berlin, Germany, 13509
Universitätsklinikum Hamburg Eppendorf
Hamburg, Germany, 20251
Sponsors and Collaborators
Medtronic Bakken Research Center
Principal Investigator: H.-C- Ehlers, MD Vivantes Klinikum am Urban
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00170261     History of Changes
Other Study ID Numbers: CEN_G_CA_4
Study First Received: September 12, 2005
Last Updated: October 8, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Medtronic Bakken Research Center:
Syncope of uncertain etiology
Repeated presyncopes

Additional relevant MeSH terms:
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014