Electrical Cardioversion of Atrial Fibrillation Clinical Trial
Near infrared spectroscopy (NIRS) is a technique that measures regional cerebral oxygenation
in a non-invasive manner. Through the use of near infrared light, the difference between
oxygenated and deoxygenated hemoglobin can be measured. By applying the Lambert-Beer law, a
numeric result can be calculated.
Since atrial fibrillation (AF) has been linked with an increased risk for the development of
neurocognitive deficits, a longer period of AF might be associated with a higher risk for
neurocognitive deficits.
It is hypothesized that there is an increase in the regional cerebral oxygen saturation
(rSO2) of patients with paroxysmal or persistent AF after successful cardioversion.
Written informed consent by the patient is asked before cardioversion and participation in
the study. Patient anamnesis is assessed by standardized questionnaire.
Patients perform several standardised neurocognitive tests to obtain a general view on the
neurocognitive status (auditory verbal learning test, mini-mental state examination, trail
making A and B, digit-symbol coding and RAND 36 Health Survey).
Cerebral oxygenation is observed during cardioversion by means of the SenSmart Model X-100
(Nonin). Additional parameters (pulse oximetry, cardiac output, arterial blood pressure,
6-lead electrocardiography (ECG), left ventricular ejection fraction) are recorded. All
measurements are performed non-invasively. Patients receive standard treatment following the
clinical guidelines.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care