ELIAS: Early Loop-Recorder in Suspected Arrhythmogenic Syncope

Syncope Clinical Trial

Official title:

Early Loop-Recorder in Suspected Arrhythmogenic Syncope

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00170261
• Other study ID #: CEN_G_CA_4
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: April 4, 2018
• Start date: April 2002
• Est. completion date: September 2006

Study information

• Verified date: April 2018
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2006
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Syncope

Intervention

Device:
• Use of an Implantable Loop Recorder

Locations

Country	Name	City	State
Germany	Humbold Klinikum	Berlin
Germany	Vivantes Klinikum am Urban	Berlin
Germany	Universitätsklinikum Hamburg Eppendorf	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center	Medtronic

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost of diagnostics per patient until final cardiac diagnosis has been made
Secondary	Cost of diagnostics until final diagnosis has been made
Secondary	Rate of correct cardiac diagnoses
Secondary	Comparison of time needed to make a diagnosis
Secondary	Comparison of pre-syncopes and syncopes occuring in both groups after enrollment