Assessment of Catheter Tissue Contact in PFA

Starting soon · Not applicable

Conditions studied: Atrial Fibrillation (AF)

In brief

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 facts

Study ID

NCT07721948

Run by

University Medical Centre Ljubljana

People needed

60

Starts

2026-09-01

Expected to finish

2028-09-01

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with electrocardiographically documented paroxysmal atrial fibrillation (AF), defined according to the European Heart Rhythm Association (EHRA) guidelines

You may not qualify if…

• Contraindication to pulsed field ablation in the left atrium (e.g., presence of a left atrial appendage occlusion device).
• Contraindication to undergoing the procedure under general anesthesia.
• Age >80 years.
• Markedly enlarged left atrium (diameter >50 mm on echocardiography, LAVI >50 mL/m²).
• Life expectancy <1 year.
• Acute life-threatening illness.
• Presence of left atrial thrombus.
• Secondary atrial fibrillation.
• Previous left atrial ablation.

Where it is running

• University Medical Centre Ljubljana — Ljubljana, Slovenia

Full record on ClinicalTrials.gov

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