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Pulsed Field (PF) Ablation System for Atrial Fibrillation (OMNY-AF Trial)

N/A
Recruiting
Research Sponsored by Biosense Webster, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 12
Awards & highlights

Summary

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Reporting Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT] or Atrial Flutter [AFL] of Unknown Origin) Episodes
Number of Participants with Primary Adverse Events (PAEs)
Secondary study objectives
Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pulsed Field (PF) Ablation SystemExperimental Treatment1 Intervention
Participants with PAF will undergo pulsed field ablation procedure with the OMNYPULSE™ catheter in combination with TRUPULSE™ generator for PVI and to deliver pulsed field (PF) energy for treatment of atrial fibrillation. Study participants will be followed for 12 months after the study index procedure.

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Who is running the clinical trial?

Biosense Webster, Inc.Lead Sponsor
125 Previous Clinical Trials
36,617 Total Patients Enrolled
84 Trials studying Atrial Fibrillation
28,534 Patients Enrolled for Atrial Fibrillation
Biosense Webster, Inc. Clinical TrialStudy DirectorBiosense Webster, Inc.
5 Previous Clinical Trials
5,320 Total Patients Enrolled
4 Trials studying Atrial Fibrillation
320 Patients Enrolled for Atrial Fibrillation
~293 spots leftby May 2026
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