ELIAS: Early Loop-Recorder in Suspected Arrhythmogenic Syncope

June 30, 2025 updated by: Medtronic Cardiac Rhythm and Heart Failure

Early Loop-Recorder in Suspected Arrhythmogenic Syncope

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10967
        • Vivantes Klinikum Am Urban
      • Berlin, Germany, 13509
        • Humbold Klinikum
      • Hamburg, Germany, 20251
        • Universitatsklinikum Hamburg Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Collaborators

Medtronic

Investigators

  • Principal Investigator: H.-C- Ehlers, MD, Vivantes Klinikum Am Urban

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimated)

September 15, 2005

Study Record Updates

Last Update Posted (Actual)

July 3, 2025

Last Update Submitted That Met QC Criteria

June 30, 2025

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEN_G_CA_4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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