Ablation of Arrhythmia's
Conditions
Keywords
Atrial fibrillation, Pulmonary vein isolation, Cerebral microembolization, Pulsed field ablation
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.
Detailed description
This study is designed as a prospective, randomized, parallel-group interventional trial conducted at Clinical Hospital Dubrava, Zagreb, Croatia and University Hospital Center Sisters of Charity, Zagreb, Croatia. The study will include adult patients with paroxysmal or persistent atrial fibrillation who have a clinical indication for catheter ablation with pulmonary vein isolation. Eligible patients will be randomized using a computer-generated randomization sequence to undergo pulmonary vein isolation with one of the following pulsed field ablation systems: PulseSelect, Varipulse, Farapulse, Sphere-9, or Sphere-360. All procedures will be performed according to standard clinical practice, with continuous periprocedural anticoagulation in accordance with current guidelines. Cerebral microembolization will be assessed using transcranial Doppler. The examination will be performed immediately before the ablation procedure and repeated after the procedure. The presence and number of microembolic signals will be recorded. This will allow assessment of changes in microembolic signal burden within each group and comparison of these changes between different pulsed field ablation systems. Demographic, clinical, and procedural data will be collected, including age, sex, type of atrial fibrillation, comorbidities, procedure duration, number of ablation applications, and procedural complications. The study will also record procedure-related clinical neurological events. The primary outcome will be the difference in the change in the number of microembolic signals before and after the procedure, expressed as ΔMES, between the different pulsed field ablation systems. Secondary outcomes will include within-group changes in microembolic signal burden, incidence of new microembolic signals after the procedure, association between procedural parameters and ΔMES, and occurrence of procedure-related neurological events.
Interventions
DEVICEPulsed field ablation using PulseSelect system
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.
DEVICEPulsed field ablation using Varipulse system
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.
DEVICEPulsed field ablation using Farapulse system
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
DEVICEPulsed field ablation using Sphere-9 system
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.
DEVICEPulsed field ablation using Sphere-360 system
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
Sponsors
Ivan Zeljkovic
University Hospital Dubrava
University Hospital Center Sisters of Charity, Zagreb, Croatia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in microembolic signal burden after pulmonary vein isolation | During procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Within-group change in microembolic signal burden | During procedure | 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. |
| Incidence of new microembolic signals after ablation | Immediately after the ablation procedure | Proportion of participants with newly detected cerebral microembolic signals on transcranial Doppler after pulmonary vein isolation. |
| Procedure-related clinical neurological events | From the start of the ablation procedure through 72 hours after the procedure | Occurrence of clinically evident neurological events related to the ablation procedure, including stroke or transient ischemic attack. |
| Association between procedure duration and ΔMES | During procedure | Association between total procedure duration and the change in cerebral microembolic signal burden before and after pulmonary vein isolation. |
| Association between number of ablation applications and ΔMES | During procedure | Association between the number of pulsed field ablation applications delivered during pulmonary vein isolation and the change in cerebral microembolic signal burden before and after the procedure. |
Countries
Croatia
Contacts
CONTACTIvan Zeljković, PhD,MD
CONTACTMihovil Santini, MD
Outcome results
None listed