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
Qualifiers
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
Treatments tested in this trial
- Electrode tissue contact assessment during pulsed field ablation
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
University Medical Centre Ljubljana
Lead sponsor
Medtronic
Collaborator
Source ClinicalTrials.gov