ELIAS: Early Loop-Recorder in Suspected Arrhythmogenic Syncope

Medtronic Cardiac Rhythm and Heart Failure100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

100

Conditions

Syncope

Interventions

Use of an Implantable Loop RecorderDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (3)

Vivantes Klinikum am Urban

Berlin, Germany

Humbold Klinikum

Berlin, Germany

Universitätsklinikum Hamburg Eppendorf

Hamburg, Germany

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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