Skip to main content
Clinical Trials/NCT05048004
NCT05048004RecruitingNot Applicable

Cerebral Embolization During Pulmonary Vein Isolation: an Observational Study

Charite University, Berlin, Germany1 site in 1 country20 target enrollmentStarted: December 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
20
Locations
1
Primary Endpoint
Microembolic Signals (MES)

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Microembolic Signals (MES)

Time Frame: during the procedure

number of MES detected by transcranial doppler ultrasound

Secondary Outcomes

  • neurological outcome(at baseline, 0-5 days after pulmonary vein isolation)
  • cerebral infarctions(at baseline, 0-5 days after pulmonary vein isolation)
  • cerebral macrobleeds(at baseline, 0-5 days after pulmonary vein isolation)
  • cognitive outcome(at baseline, 0-5 days after pulmonary vein isolation)
  • cerebral microbleeds(at baseline, 0-5 days after pulmonary vein isolation)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Christian Nolte

Principal Investigator

Charite University, Berlin, Germany

Study Sites (1)

Loading locations...

Similar Trials

Cerebral Embolization During Pulmonary... | Clinical Trial