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