Ablation With the PFA System With a Large-Area Focal Catheter for the Treatment of Persistent Atrial Fibrillation

Prior treatment

• Prior cardiac ablation or surgical procedure (including left atrial appendage (LAA) device or occlusion, or valvular cardiac procedure)
• History of thromboembolic event within 6 months prior to Index Ablation Procedure or evidence of intracardiac thrombus at time of the Index Ablation Procedure
• Any of the following events within 3 months prior to the Index Ablation Procedure:
  • Myocardial infarction
  • Unstable angina
  • Percutaneous coronary intervention
  • Heart surgery including coronary artery bypass grafting
  • Heart failure hospitalization
  • Cerebral ischemic event (stroke or transient ischemic attack (TIA))
  • Clinically significant bleeding requiring surgical intervention
  • Pericardial effusion
  • Ventriculotomy or atriotomy

Other illness

• AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other reversible/non-cardiac causes
• Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during study participation
• Presence of any permanent pacemaker, biventricular pacemaker, or implantable cardiac defibrillator (with or without biventricular pacing function) that cannot be programmed, per the manufacturer's recommendations, during the ablation procedure
• Patient cannot be removed from AADs for reasons other than AF, which includes participants with Wolff-Parkinson-White (WPW) Syndrome and participants with a history of ventricular tachycardia (VT)
• Presence of any mechanical or biologic prosthetic heart valve
• Hemodynamically significant valvular disease as determined by the Investigator
• History of pericarditis
• History of Rheumatic heart disease
• New York Heart Association (NYHA) Class IV congestive heart failure
• Primary pulmonary hypertension

Lab values

• Documented left ventricular ejection fraction (LVEF) ≤35% measured by acceptable cardiac testing (e.g., TTE, cardiac CT, etc.) within 6 months prior to enrollment
• Serious or untreated medical conditions that would prevent participation in the study, interfere with assessment or therapy, or confound data or is interpretation, including but not limited to:
  • Solid organ or hematologic transplant, or currently being evaluated for organ transplant
  • Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea
  • Chronic renal insufficiency with eGFR \<50 mL/min/1.73 m2, any history of renal dialysis, or history of renal transplant
  • Active malignancy or history of treated cancer within 24 months prior to enrollment
  • History of severe esophageal ulcers, strictures, esophagitis, esophageal structural abnormality, and uncontrolled/untreated gastroesophageal reflux disease (GERD)
  • Active systemic infection
  • Clinically significant psychological condition that, in the Investigator's opinion, would prohibit the participant's ability to meet the protocol requirements
  • Predicted life expectancy \<1 year

Other

• Long-standing persistent AF (continuous AF sustained \> 1 year)
• Presence of any IVC filters
• Presence of an interatrial baffle or patch
• Presence of any pulmonary vein stents
• Pre-existing pulmonary vein stenosis
• Pre-existing hemidiaphragmatic paralysis
• Atrial or ventricular septal defect closure
• Atrial myxoma
• Hypertrophic cardiomyopathy
• Significant or symptomatic hypotension
• Thrombocytosis, thrombocytopenia
• Contraindication to, or unwillingness to use, systemic anticoagulation
• Patient contraindicated for CT or MRI
• Sensitivity to contrast media not controlled by premedication
• Women known to be pregnant or breastfeeding, or any women of childbearing potential who are not on a reliable form of birth regulation method or abstinence
• Patient is participating in any other potentially confounding research

• Diagnosis of recurrent symptomatic paroxysmal AF (PAF) or persistent AF (PerAF) with the following documentation:
  • Paroxysmal AF (Phase A participants)
  • Physician's note indicating symptoms consistent with recurrent symptomatic PAF AND
  • At least one documented episode of AF captured continuously on 12-lead ECG, or for at least 30 seconds on transtelephonic monitor (TTM), Holter monitor, telemetry strip, or similar within 12 months prior to enrollment
  • Persistent AF (Phase A, B, and C participants)
  • Physician's note indicating symptoms consistent with recurrent symptomatic PerAF AND
  • Any 24-hour ECG recording of continuous AF within 12 months prior to enrollment OR
  • Two ECGs from any form of rhythm monitoring showing continuous AF taken at least 7 days apart within 12 months prior to enrollment OR
  • History of ≥2 direct current cardioversion (DCCV) performed within 12 months prior to enrollment
• Failure or intolerance of at least one antiarrhythmic drug (AAD) (Class I - IV) for AF, as evidenced by recurrent symptomatic PerAF or intolerable side effects due to the AAD
• Age 18 through 75 years-old on the day of enrollment
• Patient is indicated for an ablation procedure according to society guidelines or study site practice
• Patient is willing and able to give informed consent and is willing, able, and committed to participate in baseline and follow-up evaluations for the full duration of the study