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

NCT07610018 | Not Yet Recruiting

• 1 other identifier: 2026/0423-11
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Ablation of Arrhythmia's

Keywords

Atrial fibrillation; Pulmonary vein isolation; Cerebral microembolization; Pulsed field ablation

Outcome Measures

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.

  During procedure

Secondary Outcomes (5)

• Within-group change in microembolic signal burden

  During procedure

• Incidence of new microembolic signals after ablation

  Immediately after the ablation procedure

• Procedure-related clinical neurological events

  From the start of the ablation procedure through 72 hours after the procedure

• Association between procedure duration and ΔMES

  During procedure

• Association between number of ablation applications and ΔMES

  During procedure

Study Arms (5)

PulseSelect PFA

ACTIVE COMPARATOR

Participants randomized to this arm will undergo clinically indicated pulmonary vein isolation using the PulseSelect pulsed field ablation system. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.

Device: Pulsed field ablation using PulseSelect system

Varipulse PFA

ACTIVE COMPARATOR

Participants randomized to this arm will undergo clinically indicated pulmonary vein isolation using the Varipulse pulsed field ablation system. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.

Device: Pulsed field ablation using Varipulse system

Farapulse PFA

ACTIVE COMPARATOR

Participants randomized to this arm will undergo clinically indicated pulmonary vein isolation using the Farapulse pulsed field ablation system. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.

Device: Pulsed field ablation using Farapulse system

Sphere-9 PFA

ACTIVE COMPARATOR

Participants randomized to this arm will undergo clinically indicated pulmonary vein isolation using the Sphere-9 pulsed field ablation system. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.

Device: Pulsed field ablation using Sphere-9 system

Sphere-360 PFA

ACTIVE COMPARATOR

Participants randomized to this arm will undergo clinically indicated pulmonary vein isolation using the Sphere-360 pulsed field ablation system. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure

Device: Pulsed field ablation using Sphere-360 system

Interventions

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.

PulseSelect PFA

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.

Varipulse PFA

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

Farapulse PFA

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.

Sphere-9 PFA

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

Sphere-360 PFA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Paroxysmal or persistent atrial fibrillation
• Indication for catheter ablation with pulmonary vein isolation
• Feasibility of transcranial Doppler assessment
• Signed informed consent

You may not qualify if:

• Recent stroke or transient ischemic attack
• Significant cerebrovascular disease preventing reliable transcranial Doppler assessment
• Severe valvular or structural heart disease
• Pregnancy or breastfeeding
• Inability to receive anticoagulation

Sponsors & Collaborators

• Ivan Zeljkovic: lead
• University Hospital Center Sisters of Charity, Zagreb, Croatia: collaborator
• University Hospital Dubrava: collaborator

Study Sites (2)

UH Dubrava

Zagreb, 10000, Croatia

Location

University Hospital Center Sisters of Charity, Zagreb, Croatia

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ivan Zeljković, PhD,MD

CONTACT

+385917823289; ivanzeljkov@gmail.com

Mihovil Santini, MD

CONTACT

+385958101778; 023miho@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator and Head of Diagnostic and Therapeutic Department for Cardiac Electrostimulation and Electrophysiology

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 27, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 20, 2027
• Last Updated: May 27, 2026

Record last verified: 2026-05

Locations

CR (2)