TCD-CA: Cerebral Embolization During Pulmonary Vein Isolation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 that are applied in clinical routine as well as different periprocedural anticoagulation regimes.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| periprocedural oral anticoagulation Oral anticoagulation will be continued without a periprocedural pause |
Procedure: Pulmonary Vein Isolation
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). For comparison, 35 W on the anterior and 20 W on the posterior left atrium will be used. Furthermore, different periprocedural regimes of oral anticoagulation (continuous vs. minimally interrupted) will be compared.
|
| no periprocedural oral anticoagulation Pause of oral anticoagulation on the day of the intervention |
Procedure: Pulmonary Vein Isolation
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). For comparison, 35 W on the anterior and 20 W on the posterior left atrium will be used. Furthermore, different periprocedural regimes of oral anticoagulation (continuous vs. minimally interrupted) will be compared.
|
Outcome Measures
Primary Outcome Measures
- Microembolic Signals (MES) [during the procedure]
number of MES detected by transcranial doppler ultrasound
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
patients with atrial fibrillation undergoing catheter-based ablation at Charité-Campus Benjamin Franklin
-
age 18 years or older
Exclusion Criteria:
-
pregnancy
-
patient unable to provide written informed consent
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contraindications to cerebral MRI (e.g. pacemaker, mechanic valve implant, cochlea implant, severe claustrophobia)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Charité-University Medicine Berlin, Campus Benjamin Franklin | Berlin | Germany | 12203 |
Sponsors and Collaborators
- Charite University, Berlin, Germany
Investigators
- Principal Investigator: Christian H Nolte, MD, Charite University, Berlin, Germany
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EA1/215/20