Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System
Trial Parameters
Brief Summary
This is a multicenter, prospective, single-arm, feasibility study to evaluate the safety and effectiveness of the waveforms being delivered using the FARAPULSE PFA System in patients with Paroxysmal Atrial Fibrillation (PAF) and Persistent Atrial Fibrillation (PersAF).
Eligibility Criteria
Inclusion Criteria: 1. ≥ 18 years of age, or older if required by local law 2. Persistent Atrial Fibrillation or Paroxysmal Atrial Fibrillation 1. Persistent AF Documented: * Physician's note confirming the presence of persistent atrial fibrillation and the arrhythmia symptoms * Within 180 days prior to enrollment: A 24-hour continuous ECG recording confirming continuous AF OR Two (2) ECGs from any regulatory-cleared rhythm monitoring device showing continuous AF taken at least 7 days apart. OR 2. Paroxysmal AF Documented: * Physician's note confirming the presence of paroxysmal atrial fibrillation and the arrhythmia symptoms * Within 180 days of the Enrollment Date, one (1) ECG from any regulatory-cleared rhythm monitoring device showing AF 3. Willing and capable of providing informed consent 4. Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center Exclusion Criteria: 1.