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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.
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 +)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QMODE intervention | catheter ablation performed using high-power with a maximum of up to 50 W (QMODE) and |
| |
| QMODE+ intervention | catheter ablation performed using very high power with a maximum of up tp 90 W (QMODE +) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QMODE intervention | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Microembolic Signals (MES) | number of MES detected by transcranial doppler ultrasound | during the procedure |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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all patients who undergo pulmonary vein isolation as part of their treatment for atrial fibrillation at Charité-Campus Benjamin Franklin are eligible for study participation. Clinical indication for the procedure will be established by the treating physician prior to and irrespective of study participation. Patients who are unable to provide written informed consent will not be included in this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tim B Brämswig, MD | Contact | +4930450560624 | tim-bastian.braemswig@charite.de | |
| Regina von Rennenberg, MD | Contact | +493084454285 | regina-irene.freiin-von-rennenberg@charite.de |
| Name | Affiliation | Role |
|---|---|---|
| Christian H Nolte, MD | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité-University Medicine Berlin, Campus Benjamin Franklin | Recruiting | Berlin | 12203 | Germany |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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|
| QMODE+ intervention | Procedure | 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. |
|
| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |