ELIAS: Early Loop-Recorder in Suspected Arrhythmogenic Syncope

This study has been completed.

Sponsors and Collaborators:	Medtronic Bakken Research Center Medtronic
Information provided by:	Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:	NCT00170261

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 IV

MedlinePlus related topics: Fainting

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Early Loop-Recorder in Suspected Arrhythmogenic Syncope

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

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

Keywords provided by Medtronic Bakken Research Center:

Syncope of uncertain etiology
Repeated presyncopes

Study placed in the following topic categories:

Signs and Symptoms
Unconsciousness
Consciousness Disorders

Neurologic Manifestations
Neurobehavioral Manifestations
Syncope

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009