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PULSed Field Ablation for Atrial Fibrillation Using a Balloon for Early Intervention - Study

Study acronym: PULSE
StatusRecruiting
PhaseNot applicable
Started2026-08-19
View on ClinicalTrials.gov ↗

Amendment history

2026-08-21
minor
Study Status v3
Re-verified, no change to tracked fields
2026-08-20
notable
Study Status, Contacts/Locations v2
Recruitment opened
Trial sites expanded: 1 → 10 locations
Start dateestimated 2026-08-17→confirmed 2026-08-19
2026-08-10
minor
Study Status, Contacts/Locations v1
Start date2026-07-01→2026-08-17
Study sites0→1
2026-05-27
minor
Original filing
This study is a prospective, multicenter, randomized, open-label, blinded end-point, controlled clinical trial to investigate the impact of first line pulsed field ablation during 12 months follow-up in patients with early-stage paroxysmal or persistent atrial fibrillation (\<3 years) compared to usual care, defined as OMT.
Trial Details
NCT Number NCT07621003
Lead Sponsor Asklepios proresearch
Collaborators: Atrial Fibrillation Network, Abbott
Conditions Atrial Fibrillation
Enrollment 264 participants
Start Date 2026-08-19
Primary Completion 2030-03-31 (estimated)
Study Completion 2031-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-24