The primary objective of this study is to determine whether low-voltage areas (LVA)-guided catheter ablation combined with superior vena cava (SVC) isolation and pulmonary vein isolation (PVI), performed using the balloon-in-basket Volt™ pulsed field ablation PFA system, is superior to PVI alone using same technology in reducing arrhythmia recurrence at 6 and 12 months in patients with persistent AF and detectable significant LVAs on three-dimensional electroanatomical mapping.
Moreover, the study will investigate, in a separate randomized cohort, the effect of adding SVC isolation to PVI using the balloon-in-basket Volt™ PFA system, compared with PVI alone, in patients with persistent AF without detectable significant LVAs during three-dimensional electroanatomical mapping.
Age ≥18 years
Persistent AF, defined as continuous AF lasting at least 7 days
Indication for catheter ablation according to the latest ESC guidelines
Written informed consent
Inability or unwillingness to provide informed consent
Continuous AF duration duration of ≥2 years
Documented atrial tachycardia or atrial flutter
Previous left atrial catheter ablation or cardiac surgery
Parallel
Volt™ Pulsed Field Ablation System
DeviceSVC isolation
Volt™ Pulsed Field Ablation System
DevicePVI alone
Recurrence of atrial arrhythmias defined as atrial fibrillation, atrial flutter or atrial tachycardia lasting ≥30 seconds occurring after a 2-month post-procedural blanking period.
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This trial is not recruiting at the moment. You can still explore other options:
