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A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)

Study acronym: OMNY-AF
StatusActive, Not Recruiting
PhaseNot applicable
Started2024-06-28
View on ClinicalTrials.gov ↗
The purpose of this study is to demonstrate the safety and 12-month effectiveness of the BWI OMNYPULSE™ pulsed field ablation (PFA) platform for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF), an irregular heart rate that causes abnormal blood flow.

Amendment history 5 changes detected by DataLookout

2026-09-01
Enrollment closed, study ongoing
2026-09-01
Final enrollment: 353 participants (planned 440)
2026-09-01
Trial sites reduced: 46 → 41 locations
2026-09-01
Primary completion pushed: 2026-05-30 → 2027-07-31
2026-09-01
Completion pushed: 2026-06-30 → 2027-07-31
Trial Details
NCT Number NCT06455098
Lead Sponsor Biosense Webster, Inc.
Conditions Atrial Fibrillation
Enrollment 353 participants
Start Date 2024-06-28
Primary Completion 2027-07-31 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-31