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Assessment of Catheter Tissue Contact in PFA
Sponsor: University Medical Centre Ljubljana
Summary
Pulmonary vein isolation remains the cornerstone of invasive treatment for atrial fibrlllation. Despite recent technological advances in the field of pulsed field ablation (PFA) pulmonary vein isolation durability and arrhythmia free success rates remain approximately at the level of previous years and the radiofrequency ablation era. Isolation durability during PFA procedures might be enhanced by: 1. Intraprocedural monitoring contact of catheter electrode to atrial tissue. 2. Intraprocedural assessment of the transmurality of irreversible electroporation lesion. The aim of our study is to use intracardiac electrogram (iEGM) based analysis for assessment of catheter-tissue contact and PFA lesion durability.
Official title: Assessment of Electrode-tissue Contact and Pulmonary Vein Isolation Durability After Pulsed Field Ablation With a Circular "Single Shot" Catheter in Patients With Paroxysmal Atrial Fibrillation
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-09-01
Completion Date
2028-09-01
Last Updated
2026-07-23
Healthy Volunteers
No
Conditions
Interventions
Electrode tissue contact assessment during pulsed field ablation
Pulsed field ablation (PFA) catheter electrode - tissue contact assessment based on analysis of bipolar intracardiac electrocardiograms: a multipolar PFA catheter will be used for pulmonary vein isolation in a manual mode, which means that instead of delivering fully therapeutic four ablative high voltage pulse trains at each location around pulmonary veins, each of those pulse trains will be delivered manually. Changes (voltage, shape,...) in bipolar intracardiac electrocardiograms (iEGM) measured with ablative catheter electrodes will be assessed after each manual pulse train delivery.
Locations (1)
University Medical Centre Ljubljana
Ljubljana, Slovenia