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Cerebral Microembolization During Pulmonary Vein Isolation: Comparison of Different Pulsed Field Ablation Systems

ConditionAblation of Arrhythmia's
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIvan Zeljkovic

About this trial

This prospective, randomized, parallel-group interventional study will compare cerebral microembolization during pulmonary vein isolation between different pulsed field ablation systems in patients with paroxysmal or persistent atrial fibrillation. Adult patients with an indication for catheter ablation will be randomized to one of the included ablation systems: PulseSelect, Varipulse, Farapulse, Sphere-9, or Sphere-360. Microembolic signals will be assessed using transcranial Doppler before and after the procedure. The primary outcome will be the difference in the change in microembolic signal burden, expressed as ΔMES, between the different ablation systems.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

Paroxysmal or persistent atrial fibrillation

Indication for catheter ablation with pulmonary vein isolation

Feasibility of transcranial Doppler assessment

Disqualifiers

Recent stroke or transient ischemic attack

Significant cerebrovascular disease preventing reliable transcranial Doppler assessment

Severe valvular or structural heart disease

Pregnancy or breastfeeding

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pulsed field ablation using PulseSelect system

    Device

    Pulmonary vein isolation will be performed using the PulseSelect pulsed field ablation system in patients with paroxysmal or persistent atrial fibrillation undergoing clinically indicated catheter ablation. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.

  • Pulsed field ablation using Varipulse system

    Device

    Pulmonary vein isolation will be performed using the Varipulse pulsed field ablation system in patients with paroxysmal or persistent atrial fibrillation undergoing clinically indicated catheter ablation. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.

  • Pulsed field ablation using Farapulse system

    Device

    Pulmonary vein isolation will be performed using the Farapulse pulsed field ablation system in patients with paroxysmal or persistent atrial fibrillation undergoing clinically indicated catheter ablation. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedu

  • Pulsed field ablation using Sphere-9 system

    Device

    Pulmonary vein isolation will be performed using the Sphere-9 pulsed field ablation system in patients with paroxysmal or persistent atrial fibrillation undergoing clinically indicated catheter ablation. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.

  • Pulsed field ablation using Sphere-360 system

    Device

    Pulmonary vein isolation will be performed using the Sphere-360 pulsed field ablation system in patients with paroxysmal or persistent atrial fibrillation undergoing clinically indicated catheter ablation. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure

Treatment groups

100 Participants
are divided into 5 treatment groups
Group A: PulseSelect PFAActive comparator 1 intervention
Group B: Varipulse PFAActive comparator 1 intervention
Group C: Farapulse PFAActive comparator 1 intervention
Group D: Sphere-9 PFAActive comparator 1 intervention
Group E: Sphere-360 PFAActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in microembolic signal burden after pulmonary vein isolation

Difference in the number of cerebral microembolic signals detected by transcranial Doppler before and after pulmonary vein isolation, expressed as ΔMES, compared between the different pulsed field ablation systems.

Time frame
During procedure

Secondary outcomes

1

Within-group change in microembolic signal burden

Change in the number of cerebral microembolic signals detected by transcranial Doppler before and after pulmonary vein isolation within each pulsed field ablation system group.

Time frame
During procedure
2

Incidence of new microembolic signals after ablation

Proportion of participants with newly detected cerebral microembolic signals on transcranial Doppler after pulmonary vein isolation.

Time frame
Immediately after the ablation procedure
3

Procedure-related clinical neurological events

Occurrence of clinically evident neurological events related to the ablation procedure, including stroke or transient ischemic attack.

Time frame
From the start of the ablation procedure through 72 hours after the procedure
4

Association between procedure duration and ΔMES

Association between total procedure duration and the change in cerebral microembolic signal burden before and after pulmonary vein isolation.

Time frame
During procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ivan Zeljkovic

Lead sponsor

University Hospital Dubrava

Sponsor institution

University Hospital Dubrava

Collaborator

University Hospital Center Sisters of Charity, Zagreb, Croatia

Collaborator

Source ClinicalTrials.gov

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