PULSED – AF PAS

PULSED AF Post-Approval Study, an Addendum to the PulseSelect™ PFA Global Registry

Objective

PULSED AF PAS is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months.

Study Arms

N/A

Eligibility

• A diagnosis of recurrent symptomatic paroxysmal AF or persistent AF
• Failure or intolerance of at least one Class I or III antiarrhythmic drug
• Patient is ≥ 18 years of age
• Planned pulmonary vein isolation procedure with the commercially available PulseSelect™ PFA System
• Willing and able to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements

NCT ID

NCT06578104