Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System

ConditionsParoxysmal Atrial Fibrillation Persistent Atrial Fibrillation

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorBoston Scientific Corporation

About this trial

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

Qualifiers

≥ 18 years of age, or older if required by local law

Persistent Atrial Fibrillation or Paroxysmal Atrial Fibrillation

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.

Disqualifiers

Left atrial anteroposterior diameter ≥ 5.5 cm, or if LA diameter is not available, LA non-indexed volume > 100 mL. If both values are available, only the LA diameter will be used to confirm eligibility.

Any prior atrial endocardial, epicardial, or surgical ablation procedure for arrhythmia other than ablation for right-sided SVT or cavotricuspid isthmus ablation

Any prior atrial surgery

Current atrial myxoma