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

Recruiting N/A Interventional Study
Atrial Fibrillation
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
440 (estimated)
Sponsor
Biosense Webster, Inc. · Industry
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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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Diagnosed with symptomatic paroxysmal AF with: 1. At least two symptomatic AF episodes within last six months from enrollment 2. At least one electrocardiographically documented AF episode within twelve months prior to enrollment * Failed at least one Class I or Class III…
Contacts

Study Contact

949-789-3919

rshar120@its.jnj.com

CONTACT