Assessment of Catheter Tissue Contact in PFA
ConditionAtrial Fibrillation (AF)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Medical Centre Ljubljana
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with electrocardiographically documented paroxysmal atrial fibrillation (AF), defined according to the European Heart Rhythm Association (EHRA) guidelines
Disqualifiers
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).
Trial design
Design model
Sequential
Treatments tested in this trial
Electrode tissue contact assessment during pulsed field ablation
DevicePulsed 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Catheter - tissue contact assessmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
During index procedure.2
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).
Time frame
From index procedure until 6-8 week mandatory reassessment procedure.Secondary outcomes
1
Recurrence of arrhythmia
Recurrence based on registration of 30 second or longer episodes of atrial fibrillation/atrial flutter/atrial tachycardia on 7-day holter electrocardiogram or arrhythmia recorded on 12-lead surface electrocardiogram at 3, 6 and 12 monthy after index procedure. If available, additional symptom driven holter ECG or 12-lead electrocardiogram recordings will be used for analysis.
Time frame
From index procedure until completed 12 month follow-up.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Medical Centre Ljubljana
Lead sponsor
Medtronic
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: