NCT05048004

Cerebral Embolization During Pulmonary Vein Isolation

Cerebral Embolization During Pulmonary Vein Isolation: an Observational Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 +)

Conditions

• Atrial Fibrillation
• Ischemic Stroke
• Cerebral Microembolism

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-12-01
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2021-09-17
• Last updated: 2024-08-20

Locations

1 site across 1 country: Germany