Assessment of Catheter Tissue Contact in PFA

NCT07721948 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: ASSESS PFA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 1.Intraprocedural monitoring contact of catheter electrode to atrial tissue.
2. 2.Intraprocedural assessment of the transmurality of irreversible electroporation lesion.

Conditions

Atrial Fibrillation (AF)

Keywords

Atrial Fibrillation; Pulsed field ablation; Intracardiac electrogram; Pulse Select; Contact assessment

Outcome Measures

Primary Outcomes (2)

• Assessment of contact

  Assessment of contact (electrode - tissue) based on analysis of intraprocedural characteristics and acute changes of bipolar iEGMs: when bipolar iEGM voltage amplitude will decrease significantly after first manual ablative pulse train delivery the contact will be considered as good, in contrast to no or minimal change in bipolar iEGM amplitude when contact will be considered as poor.

  During index procedure.

• Assessment of PFA lesion durability

  Assessment of PFA lesion durability based on analysis of intraprocedural characteristics and changes of unipolar intracardiac electrocardiograms (iEGM). Additionally to bipolar iEGM changes during index procedure for used for contact assessment also the unipolar iEGM changes will be followed with an assumption that prolonged and unchanged increased unipolar iEGM amplitude after PFA delivery at each location correlates with transmural PFA lesion formation that leads to durable ablation lesions and durable pulmonary vein isolation.This durability of ablation lesions and pulmonary vein isolation will be assessed at mandatory reassessment procedures (remapping procedures with a high-density mapping catheter).

  From index procedure until 6-8 week mandatory reassessment procedure.

Secondary Outcomes (1)

• Recurrence of arrhythmia

  From index procedure until completed 12 month follow-up.

Study Arms (1)

Catheter - tissue contact assessment

EXPERIMENTAL

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.

Device: Electrode tissue contact assessment during pulsed field ablation

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.

Catheter - tissue contact assessment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead
• Medtronic: collaborator

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Damijan Miklavčič, PhD

  University of Ljubljana

  STUDY CHAIR

Central Study Contacts

Matevž Jan, MD, PhD

CONTACT

0038615228238; matevz.jan@kclj.si

Tine Prolič Kalinšek, MD

CONTACT

0038615228238; tine.prolic.kalinsek@kclj.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Electrophysiology Laboratory

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 23, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 1.9.2026-1.9.2028
• Access Criteria: Upon request with a proposal that describes planned analyses and anticipated results. Request must be made directly to the Principal investigator using contact information. Requests will be reviewed by the Principal investigator and Study chair.

Locations

SL (1)