Back to resultsELIAS: Early Loop-Recorder in Suspected Arrhythmogenic Syncope
Primary Purpose
Syncope
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Use of an Implantable Loop Recorder
Sponsored by
About this trial
This is an interventional diagnostic trial for Syncope focused on measuring Syncope of uncertain etiology, Repeated presyncopes
Eligibility Criteria
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
Sites / Locations
- Vivantes Klinikum am Urban
- Humbold Klinikum
- Universitätsklinikum Hamburg Eppendorf
Outcomes
Primary Outcome Measures
Cost of diagnostics per patient until final cardiac diagnosis has been made
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00170261
First Posted
September 12, 2005
Last Updated
April 4, 2018
Sponsor
Medtronic Bakken Research Center
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT00170261
Brief Title
ELIAS: Early Loop-Recorder in Suspected Arrhythmogenic Syncope
Official Title
Early Loop-Recorder in Suspected Arrhythmogenic Syncope
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medtronic Bakken Research Center
Collaborators
Medtronic
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syncope
Keywords
Syncope of uncertain etiology, Repeated presyncopes
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Use of an Implantable Loop Recorder
Primary Outcome Measure Information:
Title
Cost of diagnostics per patient until final cardiac diagnosis has been made
Secondary Outcome Measure Information:
Title
Cost of diagnostics until final diagnosis has been made
Title
Rate of correct cardiac diagnoses
Title
Comparison of time needed to make a diagnosis
Title
Comparison of pre-syncopes and syncopes occuring in both groups after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H.-C- Ehlers, MD
Organizational Affiliation
Vivantes Klinikum am Urban
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vivantes Klinikum am Urban
City
Berlin
ZIP/Postal Code
10967
Country
Germany
Facility Name
Humbold Klinikum
City
Berlin
ZIP/Postal Code
13509
Country
Germany
Facility Name
Universitätsklinikum Hamburg Eppendorf
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
12. IPD Sharing Statement
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ELIAS: Early Loop-Recorder in Suspected Arrhythmogenic Syncope
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