Assessment of Catheter Tissue Contact in PFA

Sponsor
University Medical Centre Ljubljana
Study ID
NCT07721948
Status
Not Yet Recruiting

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Conditions

  • Atrial Fibrillation (AF)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Electrode tissue contact assessment during pulsed field ablation — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Jul 23, 2026
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
Sep 1, 2028
Completion
Sep 1, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Catheter - tissue contact assessment
    Assessment of contact between electrodes on the pulsed field ablation (PFA) catheter and left atrial wall will be made based on change of bipolar intracardiac electrograms (iEGM) after first PFA delivery.

Primary Outcome Measure

Assessment of contact [ Time Frame: During index procedure. ]

Central Contacts

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