ELIAS: Early Loop-Recorder in Suspected Arrhythmogenic Syncope
Phase 4
Completed
- Conditions
- Syncope
- Registration Number
- NCT00170261
- Lead Sponsor
- Medtronic Bakken Research Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Cost of diagnostics per patient until final cardiac diagnosis has been made
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (3)
Humbold Klinikum
🇩🇪Berlin, Germany
Vivantes Klinikum am Urban
🇩🇪Berlin, Germany
Universitätsklinikum Hamburg Eppendorf
🇩🇪Hamburg, Germany