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ELIAS: Early Loop-Recorder in Suspected Arrhythmogenic Syncope

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00170261
First Posted: September 15, 2005
Last Update Posted: October 9, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic
Information provided by:
Medtronic Bakken Research Center
  Purpose
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
Syncope Device: Use of an Implantable Loop Recorder Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00170261


Locations
Germany
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
Medtronic
Investigators
Principal Investigator: H.-C- Ehlers, MD Vivantes Klinikum am Urban
  More Information

ClinicalTrials.gov Identifier: NCT00170261     History of Changes
Other Study ID Numbers: CEN_G_CA_4
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: October 9, 2008
Last Verified: October 2008

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

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