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

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

October 8, 2008

Start Date ^ICMJE

April 2002

Primary Completion Date

September 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Cost of diagnostics per patient until final cardiac diagnosos has been made

Change History

Complete list of historical versions of study NCT00170261 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

ELIAS: Early Loop-Recorder in Suspected Arrhythmogenic Syncope

Official Title ^ICMJE

Early Loop-Recorder in Suspected Arrhythmogenic Syncope

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Syncope

Intervention ^ICMJE

Device: Use of an Implantable Loop Recorder

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

100

Completion Date

September 2006

Primary Completion Date

September 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00170261

Other Study ID Numbers ^ICMJE

CEN_G_CA_4

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Medtronic Bakken Research Center

Collaborators ^ICMJE

Medtronic

Investigators ^ICMJE

Principal Investigator:

H.-C- Ehlers, MD

Vivantes Klinikum am Urban

Information Provided By

Medtronic Bakken Research Center

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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