The goal of the TCD-CA study is to determine the frequency of cerebral embolization during pulmonary vein isolation using continuous transcranial Doppler examination. Different parts of the procedure, different ablation techniques and periprocedural anticoagulation regimes will be compared.
Pulmonary vein isolation (PVI) is a well-established interventional treatment of patients with atrial fibrillation. Previous studies have shown that catheter-based treatments such as PVI may lead to cerebral ischemia. Cerebral ischemia related to PVI may present with new neurological deficits but may also occur as "silent brain infarction". However, even "silent brain infarctions" are associated with an increased risk of incident dementia and clinically overt new strokes. To date, it remains unclear which procedural steps of PVI are associated with an increased risk of cerebral ischemia. Cerebral blood flow and microembolic signals can be detected by using transcranial doppler ultrasound (TCD). TCD has been used in clinical routine for many years and is known to be safe in stroke patients. By performing continuous TCD monitoring for microembolic signals during PVI, the aim of this study is therefore to identify, which procedural steps are associated with the occurence of cerebral microemboli. In addition, the investigators aim to compare the frequency of cerebral microemboli in different pulmonary vein isolation techniques, namely high-power with a maximum of up to 50 W (QMODE) and very high power with a maximum of up tp 90 W (QMODE +)
Study Type
OBSERVATIONAL
Enrollment
20
Patients undergoing different forms of pulmonary vein isolation are being monitored for microembolic signals (MES) by transcranial ultrasound. For standard ablation, a Thermocool Smarttouch SF (Biosense Webster) catheter will be used (50 W, target ablation index of 550).
Patients undergoing different forms of pulmonary vein isolation are being monitored for microembolic signals (MES) by transcranial ultrasound. For comparison, catheter ablation performed using very high power with a maximum of up tp 90 W (QMODE +) will be used.
Charité-University Medicine Berlin, Campus Benjamin Franklin
Berlin, Germany
RECRUITINGMicroembolic Signals (MES)
number of MES detected by transcranial doppler ultrasound
Time frame: during the procedure
neurological outcome
neurological outcome will be evaluated using the National Institute of Health Stroke Scale
Time frame: at baseline, 0-5 days after pulmonary vein isolation
cognitive outcome
cognitive outcome will be evaluated using the Montreal Cognitive Assessment
Time frame: at baseline, 0-5 days after pulmonary vein isolation
cerebral infarctions
number of new cerebral infarctions on magnetic resonance imaging
Time frame: at baseline, 0-5 days after pulmonary vein isolation
cerebral microbleeds
number of new cerebral microbleeds on magnetic resonance imaging
Time frame: at baseline, 0-5 days after pulmonary vein isolation
cerebral macrobleeds
number of new cerebral macrobleeds on magnetic resonance imaging
Time frame: at baseline, 0-5 days after pulmonary vein isolation
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