Status:
COMPLETED
ELIAS: Early Loop-Recorder in Suspected Arrhythmogenic Syncope
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Collaborating Sponsors:
Medtronic
Conditions:
Syncope
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2006
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00170261
Start Date
April 1 2002
End Date
September 1 2006
Last Update
July 3 2025
Active Locations (3)
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1
Vivantes Klinikum am Urban
Berlin, Germany, 10967
2
Humbold Klinikum
Berlin, Germany, 13509
3
Universitätsklinikum Hamburg Eppendorf
Hamburg, Germany, 20251