Atrial Fibrillation, Cerebral Microembolism, Ischemic Stroke
Conditions
Brief summary
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
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 +)
Interventions
PROCEDUREQMODE intervention
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).
PROCEDUREQMODE+ intervention
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.
Sponsors
Charite University, Berlin, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microembolic Signals (MES) | during the procedure | number of MES detected by transcranial doppler ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| neurological outcome | at baseline, 0-5 days after pulmonary vein isolation | neurological outcome will be evaluated using the National Institute of Health Stroke Scale |
| cognitive outcome | at baseline, 0-5 days after pulmonary vein isolation | cognitive outcome will be evaluated using the Montreal Cognitive Assessment |
| cerebral infarctions | at baseline, 0-5 days after pulmonary vein isolation | number of new cerebral infarctions on magnetic resonance imaging |
| cerebral microbleeds | at baseline, 0-5 days after pulmonary vein isolation | number of new cerebral microbleeds on magnetic resonance imaging |
| cerebral macrobleeds | at baseline, 0-5 days after pulmonary vein isolation | number of new cerebral macrobleeds on magnetic resonance imaging |
Countries
Germany
Contacts
Primary ContactTim B Brämswig, MD
Backup ContactRegina von Rennenberg, MD
Outcome results
None listed