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

This is a prospective, single-arm, multi-center, clinical study. The study will be conducted at up to 4 centers in Europe. Up to 200 participants will be enrolled and treated.

Participants enrolled in Phase A and Phase B will be exited from the study upon completion of the remapping procedure hospital discharge. Participants enrolled in Phase C will be followed through 12 months. All eligible patients who provide written informed consent will be treated with the study device.

Inclusion criteria

• 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

Exclusion criteria

• Long-standing persistent AF (continuous AF sustained > 1 year)
• AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other reversible/non-cardiac causes
• Prior cardiac ablation or surgical procedure (including left atrial appendage (LAA) device or occlusion, or valvular cardiac procedure)
• 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 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
• 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
• 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
• New York Heart Association (NYHA) Class IV congestive heart failure
• Documented left ventricular ejection fraction (LVEF) ≤35% measured by acceptable cardiac testing (e.g., TTE, cardiac CT, etc.) within 6 months prior to enrollment
• Hypertrophic cardiomyopathy
• Primary pulmonary hypertension
• 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
• 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