ELIAS: Early Loop-Recorder in Suspected Arrhythmogenic Syncope

Medtronic

Status and phase

Completed

Phase 4

Conditions

Syncope

Treatments

Device: Use of an Implantable Loop Recorder

Study type

Interventional

Funder types

Industry

Identifiers

NCT00170261

CEN_G_CA_4

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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