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ELIAS: Early Loop-Recorder in Suspected Arrhythmogenic Syncope

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by:
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00170261
First received: September 12, 2005
Last updated: October 8, 2008
Last verified: October 2008
History of Changes
  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
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:

MedlinePlus related topics: Fainting
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

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:
Syncope
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013