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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05048004
Other study ID # EA1/215/20
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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