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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBiosense Webster, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

At least two symptomatic AF episodes within last six months from enrollment

At least one electrocardiographically documented AF episode within twelve months prior to enrollment

Failed at least one Class I or Class III antiarrhythmic drug

Willing and capable to provide consent

Disqualifiers

Previously diagnosed with persistent AF (greater than [>] 7 days in duration)

AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.

Previous surgical or catheter ablation for AF

Patients known to require ablation outside the PV ostia and outside the CTI region.

Trial design

Treatments tested in this trial

  • OMNYPULSE™ Catheter with the TRUPULSE Generator

Treatment groups

440 Participants
are divided into 1 treatment group

Sponsors and collaborators