Cerebral Embolization During Pulmonary Vein Isolation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QMODE intervention, QMODE+ intervention.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation, Ischemic Stroke, Cerebral Microembolism. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cerebral Embolization During Pulmonary Vein Isolation: an Observational Study
Overview
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
- Procedure QMODE 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). - Procedure QMODE+ 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.
Primary outcome measures
- Microembolic Signals (MES) [Time frame: during the procedure]
Secondary outcome measures (5)
- neurological outcome [Time frame: at baseline, 0-5 days after pulmonary vein isolation]
- cognitive outcome [Time frame: at baseline, 0-5 days after pulmonary vein isolation]
- cerebral infarctions [Time frame: at baseline, 0-5 days after pulmonary vein isolation]
- cerebral microbleeds [Time frame: at baseline, 0-5 days after pulmonary vein isolation]
- cerebral macrobleeds [Time frame: at baseline, 0-5 days after pulmonary vein isolation]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Charité-University Medicine Berlin, Campus Benjamin Franklin — Berlin
Identifiers
NCT: NCT05048004 · EA1/215/20