Cerebral Embolization During Pulmonary Vein Isolation

NCT ID: NCT05048004

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2025-12-31

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 +)

Conditions

Atrial Fibrillation; Ischemic Stroke; Cerebral Microembolism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

QMODE intervention

catheter ablation performed using high-power with a maximum of up to 50 W (QMODE) and

QMODE intervention

Intervention Type: 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).

QMODE+ intervention

catheter ablation performed using very high power with a maximum of up tp 90 W (QMODE +)

QMODE+ intervention

Intervention Type: 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.

Interventions

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).

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Christian Nolte

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christian H Nolte, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Charité-University Medicine Berlin, Campus Benjamin Franklin

Berlin, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Tim B Brämswig, MD

Role: CONTACT

tim-bastian.braemswig@charite.de

+4930450560624

Regina von Rennenberg, MD

Role: CONTACT

regina-irene.freiin-von-rennenberg@charite.de

+493084454285

Facility Contacts

Tim B Brämswig, MD

Role: primary

Regina von Rennenberg, MD

Role: backup

Other Identifiers

EA1/215/20

Identifier Type: -

Identifier Source: org_study_id