Cerebral Embolization During Pulmonary Vein Isolation

Recruiting

• Conditions: Cerebral Microembolism; Atrial Fibrillation; Ischemic Stroke
• Interventions: Procedure: QMODE intervention; Procedure: QMODE+ intervention

• Registration Number: NCT05048004
• Lead Sponsor: Charite University, Berlin, Germany

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 +)

Study Timeline

• Study First Submitted: 2021-08-09
• Study First Submitted QC: 2021-09-16
• Study First Posted: 2021-09-17
• Study Start: 2021-12-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
QMODE intervention	QMODE intervention	catheter ablation performed using high-power with a maximum of up to 50 W (QMODE) and
QMODE+ intervention	QMODE+ intervention	catheter ablation performed using very high power with a maximum of up tp 90 W (QMODE +)

Primary Outcome Measures

Name	Time	Method
Microembolic Signals (MES)	during the procedure	number of MES detected by transcranial doppler ultrasound

Secondary Outcome Measures

Name	Time	Method
neurological outcome	at baseline, 0-5 days after pulmonary vein isolation	neurological outcome will be evaluated using the National Institute of Health Stroke Scale
cerebral infarctions	at baseline, 0-5 days after pulmonary vein isolation	number of new cerebral infarctions on magnetic resonance imaging
cerebral macrobleeds	at baseline, 0-5 days after pulmonary vein isolation	number of new cerebral macrobleeds on magnetic resonance imaging
cognitive outcome	at baseline, 0-5 days after pulmonary vein isolation	cognitive outcome will be evaluated using the Montreal Cognitive Assessment
cerebral microbleeds	at baseline, 0-5 days after pulmonary vein isolation	number of new cerebral microbleeds on magnetic resonance imaging

Trial Locations

Locations (1)

Charité-University Medicine Berlin, Campus Benjamin Franklin; 🇩🇪 Berlin, Germany