Clinical trial NCT05048004: Cerebral Embolization During Pulmonary Vein Isolation
Official title: Cerebral Embolization During Pulmonary Vein Isolation: an Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Ischemic Stroke
Cerebral Microembolism
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients who undergo pulmonary vein isolation as part of their treatment for atrial fibrillation at Charité-Campus Benjamin Franklin are eligible for study participation. Clinical indication for the procedure will be established by the treating physician prior to and irrespective of study participation. Patients who are unable to provide written informed consent will not be included in this study.

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 +)

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

Primary outcomes:
measure: Microembolic Signals (MES)
timeFrame: during the procedure
Secondary outcomes:
measure: neurological outcome
timeFrame: at baseline, 0-5 days after pulmonary vein isolation
measure: cognitive outcome
timeFrame: at baseline, 0-5 days after pulmonary vein isolation
measure: cerebral infarctions
timeFrame: at baseline, 0-5 days after pulmonary vein isolation
measure: cerebral microbleeds
timeFrame: at baseline, 0-5 days after pulmonary vein isolation
measure: cerebral macrobleeds
timeFrame: at baseline, 0-5 days after pulmonary vein isolation
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité-University Medicine Berlin, Campus Benjamin Franklin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Christian H Nolte, MD
role: PRINCIPAL_INVESTIGATOR
References: