Clinical Trial

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

Study acronym: LowVOLT-AF
Not Yet Recruiting
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Summary
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.
Protocol Amendment History 1 change
critical Phase changed: Phase 4 -> not applicable 2026-05-20
Trial Details
NCT Number NCT07587541
Lead Sponsor University of Luebeck
Conditions Atrial Fibrillation (AF)
Enrollment 618 participants
Start Date 2026-05-18
Primary Completion 2029-11-01 (estimated)
Study Completion 2029-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-19