PULSED AF Post-Approval Study

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

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.

PulseSelect 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 visits will occur at 3, 6, 12, 24, and 36 months post-ablation, including required 24-hour Holter monitoring at 6, 12, 24, and 36 month visits. The PulseSelect™ PFA System used in this study is market approved and the ablation procedure will be performed according to hospital standard of care.

Inclusion Criteria

• A diagnosis of recurrent symptomatic paroxysmal AF or persistent AF
• Refractory to at least one Class I or III antiarrhythmic drug (i.e., not effective, not tolerated, or not desired)
• 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

Exclusion Criteria

• Long-standing persistent AF (continuous AF sustained >12 months)
• Prior left atrial catheter or surgical ablation
• Patient with life expectancy < 36 months
• Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
• Current or anticipated participation in any other clinical trial of a drug, device, or biologic not approved by the global study manager