The NEXT PULSE study is a pre-market, prospective, multi-center, non-randomized, interventional clinical study. Adult subjects with symptomatic paroxysmal or persistent AF who provided consent will be enrolled and treated with the PulseSelect PFA System.
Adults who are ≥18 and ≤80 years of age on the day of enrollment (or older than 18 if required by local law)
Physician's note indicating at least 2 symptomatic paroxysmal AF episodes occurring within 12 months prior to enrollment; AND
at least 1 ECG documented AF episode from any form of rhythm monitoring within 12 months prior to enrollment.
Physician's note indicating at least 1 symptomatic persistent AF episode occurring within 12 months prior to enrollment; AND
Long-standing persistent AF (continuous AF that is sustained >12 months)
Paroxysmal AF patients: AF that required three (3) or more distinct cardioversions in the preceding 12 months.
Paroxysmal AF: LA anteroposterior diameter > 5.0 cm (by MRI, CT, or TTE) Persistent AF: LA anteroposterior diameter > 5.5 cm (by MRI, CT, or TTE)
Any of the following procedures, implants, or conditions at baseline: prior left atrial catheter or surgical ablation, prior left atrial percutaneous interventions including left atrial appendage occlusion, and septal closure devices
Single group
PulseSelect Pulse Field Ablation (PFA) System
DeviceAdult subjects with recurrent symptomatic paroxysmal AF or persistent AF will be enrolled and undergo ablation with the PulseSelect™ PFA system.
Safety: Number of Participants with at Least One Primary Safety Event
Primary Safety events are: Within 7 days of ablation procedure: * Heart block requiring a pacemaker * Major bleeding requiring transfusion * Myocardial infarction * Permanent phrenic nerve paralysis * Pulmonary edema * Severe pericarditis * Significant pericardial effusion/tamponade * Stroke/cerebrovascular accident (CVA) * Systemic/pulmonary embolism requiring intervention * Transient ischemic attack (TIA) * Vagal nerve injury resulting in esophageal dysmotility or gastroparesis * Vascular access complications requiring intervention * Acute Kidney Injury (AKI) requiring dialysis, new hospitalization greater than 48 hours, or prolongation of hospitalization greater than 48 hours beyond the expected discharge * Death Within 3 months post-ablation: \- Atrioesophageal fistula/Esophageal perforation (procedure and PulseSelect PFA Loop Catheter related) Within 6 months post-ablation: \- Pulmonary vein stenosis (≥70% diameter reduction)
Effectiveness: Number of Participants with Treatment Success
Treatment success is defined as freedom from documented recurrence of AF, AT, or AFL based on electrocardiographic data up to the 12-month follow-up and excluding a 90-day blanking period. Treatment failure is defined as any of the following components: * Acute procedural failure (see definition below) * Documented AF/AT/AFL after the 90-day post-ablation blanking period * Any subsequent AF catheter or surgical ablation in the LA, including repeat PVI ablation at any time during the study. * Direct current cardioversion for AF/AT/AFL recurrences after the 90-day blanking period. * Use of a Class I or III AAD at a higher daily dose than the pre-ablation maximum daily dose after the 90-day blanking period. * Initiation of a new Class I or III AAD after the 90-day blanking period. * Re-initiation after the 90-day blanking period of any dose of a Class I or III AAD that was failed or was not tolerated prior to the ablation procedure.
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