Syncope
Conditions
Keywords
Syncope of uncertain etiology, Repeated presyncopes
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.
Interventions
DEVICEUse of an Implantable Loop Recorder
Sponsors
Medtronic
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cost of diagnostics per patient until final cardiac diagnosis has been made | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Outcome results
None listed