Low-VOLTage Area-Guided Catheter Ablation and SVC Isolation for Persistent Atrial Fibrillation Using a Balloon-in-Basket Pulsed Field Ablation Catheter

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Luebeck

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Volt™ Pulsed Field Ablation System
  • Volt™ Pulsed Field Ablation System

Treatment groups

618 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators