The goal of this clinical trial is to evaluate whether pulsed field ablation (PFA) using the novel VOLT catheter is as safe and effective as conventional thermal ablation (radiofrequency or cryotherapy) for the treatment of atrial fibrillation (AF) in adult patients undergoing their first pulmonary vein isolation (PVI). The main questions it aims to answer are: * Is PFA with the VOLT catheter non-inferior to thermal ablation in preventing recurrence of atrial tachyarrhythmias 2-12 months after the procedure? * Is PFA with the VOLT catheter associated with fewer or comparable serious complications (such as cardiac tamponade, stroke, or phrenic nerve injury)? Researchers will compare the outcomes between patients receiving PFA with the VOLT catheter and those treated with thermal ablation techniques to see if PFA offers comparable or potentially better safety and efficacy. Participants will: * Be randomly assigned (1:1) to receive either pulsed field ablation (PFA) or thermal ablation (radiofrequency or cryotherapy). * Undergo standard follow-up visits at 2-3 months, 6 months, and 12 months post-ablation. * Have repeated ECGs and Holter monitoring to assess heart rhythm. * Complete quality of life questionnaires at baseline, 3, 6, and 12 months. * Use a home ECG device (Kardia Mobile) weekly during the final 3 months of the study. The study includes 136 adults (≥18 years) with paroxysmal or persistent AF, in two participating hospitals. The total study duration is 3 years, including a 2-year enrollment period and 1-year follow-up per participant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
136
Participants in this arm will undergo pulmonary vein isolation (PVI) using the VOLT catheter, a novel single-shot ablation device that delivers pulsed field energy (a non-thermal ablation method). The catheter features a balloon-in-basket design and enables electro-anatomical mapping. The procedure is performed under conscious sedation or general anesthesia and follows standard PVI protocols adapted for the PFA technology.
Participants in this arm will receive PVI using established thermal ablation techniques, either: * Radiofrequency ablation, a point-by-point technique using heat delivered through a catheter tip guided by mapping systems, or * Cryoballoon ablation, which uses freezing energy delivered via a balloon catheter. The choice between RF and cryoablation is at the discretion of the treating physician, in line with standard care.
AZ Sint-Jan Brugge AV
Bruges, Belgium
RECRUITINGUZ Brussel
Jette, Belgium
RECRUITINGTime to first recurrence of any atrial tachyarrhythmia
The primary endpoint is the time to first recurrence of any atrial tachyarrhythmia (AF and/or organized atrial tachyarrhythmia) after 12 months following the ablation procedure, as detected on repetitive Holter and home monitoring. During the first 2 months after the procedure (blanking period), recurrent AF or atrial tachycardia will be treated with antiarrhythmic drugs or cardioversion as needed, and won't be considered treatment failure. Atrial tachyarrhythmia recurrence is defined as continuous arrhythmia lasting 30 seconds or longer. Potential arrhythmia events will be independently reviewed and adjudicated by a clinical events committee comprised of 3 experienced electrophysiologists who are blinded to treatment allocation.
Time frame: Between 2 and 12 months post ablation
Number of safety events, composite of cardiac tamponade, phrenic nerve palsy, vascular complications, stroke/transient ischemic attack, atrio-esophageal fistula and death
The primary safety endpoint is a composite of: 1. Cardiac tamponade requiring pericardiocentesis 2. Persistent phrenic nerve palsy lasting more than 24 hours 3. Serious vascular complications requiring intervention 4. Stroke/transient ischemic attack 5. Atrio-esophageal fistula 6. Death The safety endpoint is assessed during catheter ablation, until discharge, and during the following 30 days. Information on safety events are collected throughout the trial by the investigators or their designees. All primary safety events will be reviewed and adjudicated by the clinical events committee members.
Time frame: From ablation until 30 days post ablation
Procedure duration (minutes)
Total procedure duration (minutes)
Time frame: Day of ablation procedure
Left atrial dwelling time (minutes)
Time the catheter remains inside the left atrium during the ablation procedure (minutes)
Time frame: Day of ablation procedure
Fluoroscopy time (minutes)
Total fluoroscopy time (minutes)
Time frame: Day of ablation procedure
AF burden: percentage of time in AF on 7 day Holter (%)
AF burden: percentage of time in AF on 7 day Holter (%)
Time frame: Before ablation, and 6 months and 12 months post ablation
Proportion of patients with recurrence of any atrial tachyarrhythmia including during the blanking period (%)
Proportion of patients with recurrence of any atrial tachyarrhythmia including during the blanking period (%)
Time frame: From ablation until 12 months post ablation
Proportion of patients undergoing a repeat ablation (%)
Proportion of patients undergoing a repeat ablation (%)
Time frame: From ablation until 12 months post ablation
Quality of life changes, assessed using the 36-Item Short Form Survey Instrument (SF-36)
Quality of life changes at 3, 6 and 12 months compared with baseline, assessed using the 36-Item Short Form Survey Instrument (SF-36)
Time frame: 3, 6 and 12 months post ablation
Quality of life changes, assessed using the AF Symptom Checklist
Quality of life changes at 3, 6 and 12 months compared with baseline, assessed using the AF Symptom Checklist
Time frame: 3, 6 and 12 months post ablation
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