Cerebral Embolization During Pulmonary Vein Isolation (TCD-CA)

Charité University Medicine Berlin

Status: Enrolling

Conditions: Ischemic Stroke; Atrial Fibrillation; Cerebral Microembolism

Treatments: Procedure: QMODE intervention; Procedure: QMODE+ intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05048004

EA1/215/20

Details and patient eligibility

About

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.

Full 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 +)

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

QMODE intervention

Description:

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

Treatment:

Procedure: QMODE intervention

QMODE+ intervention

Description:

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

Treatment:

Procedure: QMODE+ intervention