Cerebral Embolization During Pulmonary Vein Isolation

Study Overview
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Brief Summary
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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.

Detailed Description
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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 +)

Official Title
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Cerebral Embolization During Pulmonary Vein Isolation: an Observational Study

Conditions
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Atrial Fibrillation, Ischemic Stroke, Cerebral Microembolism

Intervention / Treatment
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* Procedure: QMODE intervention
* Procedure: QMODE+ intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with atrial fibrillation undergoing first-ever catheter-based ablation at Charité-Campus Benjamin Franklin age 18 years or older Exclusion Criteria: pregnancy patient unable to provide written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| QMODE intervention<br>catheter ablation performed using high-power with a maximum of up to 50 W (QMODE) and | Procedure: QMODE intervention<br>* 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).<br>|
| QMODE+ intervention<br>catheter ablation performed using very high power with a maximum of up tp 90 W (QMODE +) | Procedure: QMODE+ intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microembolic Signals (MES) | number of MES detected by transcranial doppler ultrasound | during the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neurological outcome | neurological outcome will be evaluated using the National Institute of Health Stroke Scale | at baseline, 0-5 days after pulmonary vein isolation | 
| cognitive outcome | cognitive outcome will be evaluated using the Montreal Cognitive Assessment | at baseline, 0-5 days after pulmonary vein isolation | 
| cerebral infarctions | number of new cerebral infarctions on magnetic resonance imaging | at baseline, 0-5 days after pulmonary vein isolation | 
| cerebral microbleeds | number of new cerebral microbleeds on magnetic resonance imaging | at baseline, 0-5 days after pulmonary vein isolation | 
| cerebral macrobleeds | number of new cerebral macrobleeds on magnetic resonance imaging | at baseline, 0-5 days after pulmonary vein isolation |