FARAPULSE™ Pulsed Field Ablation System

Exclusion Criteria

• •1. Subjects with a current interatrial baffle or patch
• •2. Subjects with a known or suspected atrial myxoma
• •3. Subjects with a myocardial infarction within 14 days prior to enrollment
• •4. Subjects with a recent (within 30 days prior to enrollment) Cerebral Vascular Accident (CVA)
• •5. Subjects who do not tolerate anticoagulation therapy
• •6. Subjects with an active systemic infection \*
• •7. Subjects with a presence of atrial known thrombus \*
• •8. Subjects with a known inability to obtain vascular access
• •9. Subjects who are pregnant or planning to be pregnant
• •10. Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
• •11. Subjects with any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty
• •12. Subjects with a contraindication to an invasive electrophysiology procedure where insertion or manipulation of a catheter in the cardiac chambers is deemed unsafe per physician's medical judgement, such as, but not limited to, a recent previous cardiac surgery (e.g., ventriculotomy or atriotomy, CABG, PTCA/PCI/coronary stent procedure), recent previous unstable angina and/or in patients with congenital heart disease where the underlying abnormality increases the risk of the ablation (e.g., severe rotational anomalies of the heart or great vessels)
• •13. Subjects with a life expectancy of ≤ 1 year per investigator's opinion
• •14. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be brought to the attention of the sponsor to determine eligibility.