The study will compare two ablation strategies in patients with paroxysmal or persistent atrial fibrillation undergoing repeat ablation using pulsed-field ablation: redo pulmonary vein isolation only versus redo pulmonary vein isolation with added posterior wall ablation.
Documented recurrence of paroxysmal or persistent AF following single prior catheter ablation with PVI, confirmed by 12-lead ECG, Holter monitoring, or ICM within the last 2 years.
Candidate for repeat catheter ablation according to current European Society of Cardiology (ESC) AF management guidelines.
Continuous oral anticoagulation with a vitamin K antagonist or non-vitamin K oral anticoagulant (NOAC) for ≥ 4 weeks prior to the ablation, or transoesophageal echocardiography (TEE) and/or cardiac computed tomography (CT) within 48 hours before the procedure excluding LA thrombus.
Age ≥ 18 years at the time of informed consent.
Previous LA surgery
> 1 prior LA ablation
LA ablation outside of the PVs in the first LA ablation
LA diameter >60 mm in the parasternal long axis
Parallel
Pulmonary vein isolation with posterior wall ablation
Procedure/SurgeryRedo-pulmonary vein isolation with left atrial posterior wall ablation using pulsed-field ablation technology. At the end of the procedure, an implantable cardiac monitor will be implanted for the purpose of continuous arrhythmia monitoring.
Pulmonary vein isolation without posterior wall ablation
Procedure/SurgeryRedo-pulmonary vein isolation without left atrial posterior wall ablation using pulsed-field ablation technology. At the end of the procedure, an implantable cardiac monitor will be implanted for the purpose of continuous arrhythmia monitoring.
Time to first recurrence of any atrial tachyarrhythmia day 61-365
Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation (AF), atrial flutter (AFL) or atrial tachycardia (AT)) between day 61 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will be defined as an episode of at least 120 seconds (the shortest-duration episode that could be programmed for detection on the implantable cardiac monitor) with a continuous atrial arrhythmia of at least 30 seconds.
Treatment-emergent adverse events: Cardiac tamponade requiring drainage
Number of patients with cardiac tamponade requiring drainage after PVI
Treatment-emergent adverse events: Persistent phrenic nerve palsy lasting >24 hours
Number of patients with persistent phrenic nerve palsy lasting \>24 hours after PVI
Treatment-emergent adverse events: Serious vascular complication requiring intervention
Number of patients with serious vascular complications requiring intervention after PVI
Treatment-emergent adverse events: Stroke or TIA
Number of patients with stroke or TIA after PVI
Time to first recurrence of any atrial tachyarrhythmia in patients with versus without left atrial posterior wall scar
Subgroup analysis; scar is based on the 3D pre-ablation voltage map at baseline
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University Hospital, Basel, Switzerland
Lead sponsor
Swiss Heart Foundation
Collaborator
Boston Scientific Corporation
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
