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.
This study will include subjects with a diagnosis of recurrent symptomatic Paroxysmal and Persistent AF. Following the index ablation procedure and hospital discharge, all study subjects will be followed at 7 days, 2 months, 6 months, and 12 months and will be exited from the study at the conclusion of the 12-month follow-up visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
320
Adult 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)
Time frame: Up to 6 months post procedure
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.
Time frame: Up to 12 months post procedure
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