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Assessment of Catheter Tissue Contact in PFA

NCT07721948 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-07-23

No results posted yet for this study

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.

Conditions

  • Atrial Fibrillation (AF)

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • University Medical Centre Ljubljana

    lead OTHER

Principal Investigators

  • Damijan Miklavčič, PhD · University of Ljubljana

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-09-01
Completion
2028-09-01
FDA Device
Yes

Countries

  • Slovenia

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07721948 on ClinicalTrials.gov