Cerebral Embolization During Pulmonary Vein Isolation

Atrial Fibrillation Clinical Trial

— TCD-CA  

Official title:

Cerebral Embolization During Pulmonary Vein Isolation: an Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05048004
• Other study ID #: EA1/215/20
• Status: Recruiting
• Start date: December 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Charite University, Berlin, Germany
• Contact: Tim B Brämswig, MD
• Phone: +4930450560624
• Email: tim-bastian.braemswig[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 +)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cerebral Microembolism
• Ischemic Stroke

Intervention

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).
• 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.

Locations

Country	Name	City	State
Germany	Charité-University Medicine Berlin, Campus Benjamin Franklin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microembolic Signals (MES)	number of MES detected by transcranial doppler ultrasound	during the procedure
Secondary	neurological outcome	neurological outcome will be evaluated using the National Institute of Health Stroke Scale	at baseline, 0-5 days after pulmonary vein isolation
Secondary	cognitive outcome	cognitive outcome will be evaluated using the Montreal Cognitive Assessment	at baseline, 0-5 days after pulmonary vein isolation
Secondary	cerebral infarctions	number of new cerebral infarctions on magnetic resonance imaging	at baseline, 0-5 days after pulmonary vein isolation
Secondary	cerebral microbleeds	number of new cerebral microbleeds on magnetic resonance imaging	at baseline, 0-5 days after pulmonary vein isolation
Secondary	cerebral macrobleeds	number of new cerebral macrobleeds on magnetic resonance imaging	at baseline, 0-5 days after pulmonary vein isolation