Cerebral Embolization During Pulmonary Vein Isolation: an Observational Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Charite University, Berlin, Germany
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Microembolic Signals (MES)
- Status
- Recruiting
- Last Updated
- last year
Overview
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 +)
Investigators
Christian Nolte
Principal Investigator
Charite University, Berlin, Germany
Eligibility Criteria
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
Outcomes
Primary Outcomes
Microembolic Signals (MES)
Time Frame: during the procedure
number of MES detected by transcranial doppler ultrasound
Secondary Outcomes
- neurological outcome(at baseline, 0-5 days after pulmonary vein isolation)
- cerebral infarctions(at baseline, 0-5 days after pulmonary vein isolation)
- cerebral macrobleeds(at baseline, 0-5 days after pulmonary vein isolation)
- cognitive outcome(at baseline, 0-5 days after pulmonary vein isolation)
- cerebral microbleeds(at baseline, 0-5 days after pulmonary vein isolation)