Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF

Inclusion criteria

• Failure of at least one AAD (class I or III) for AF as evidenced by recurrent symptomatic AF, or intolerable side effects due to AAD.
• A diagnosis of recurrent symptomatic paroxysmal or persistent AF:

• Symptomatic paroxysmal AF, which is defined as AF that terminates spontaneously or with intervention within 7 days of onset, documented by the following:

• physician's note indicating at least 2 symptomatic paroxysmal AF episodes occurring within 6 months prior to enrollment; and
• at least 1 ECG documented AF episode from any form of rhythm monitoring within 12 months prior to enrollment OR
• Symptomatic persistent AF, which is defined as continuous AF sustained beyond 7 days and less than 1 year, documented by the following:

• physician's note indicating at least 1 symptomatic persistent AF episode occurring within 6 months prior to enrollment; and
• any 24-hour continuous ECG recording documenting continuous AF within 6 months prior to enrollment; OR 2 ECGs from any form of rhythm monitoring taken at least 7 days apart, both showing continuous AF within 6 months prior to enrollment
• Age 18 through 80 years old (or older than 18 if required by local law)

Exclusion criteria

• Long-standing persistent AF (continuous AF that is sustained >12 months)
• Left atrial diameter > 5.0 cm (anteroposterior)
• Prior left atrial ablation or surgical procedure (including left atrial appendage closures)
• Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during the follow-up period
• Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure
• Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
• Presence of any pulmonary vein stents
• Presence of any pre-existing pulmonary vein stenosis
• Pre-existing hemidiaphragmatic paralysis
• Presence of any cardiac valve prosthesis
• Moderate to severe mitral valve stenosis
• More than moderate mitral regurgitation (i.e., 3+ or 4+ MR)
• Any cardiac surgery, myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3-month interval preceding the consent date
• Unstable angina
• NYHA Class III or IV congestive heart failure or documented left ventricular ejection fraction (LVEF) less than or equal to 35% measure by acceptable cardiac testing (e.g. TTE)
• Primary pulmonary hypertension
• Rheumatic heart disease
• Thrombocytosis, thrombocytopenia
• Any condition contraindicating chronic anticoagulation
• Active systemic infection
• Hypertrophic cardiomyopathy
• Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, and acute alcohol toxicity
• Any cerebral ischemic event (strokes or TIAs) which occurred during the 6-month interval preceding the consent date
• History of thromboembolic event within the past 6 months or evidence of intracardiac thrombus at the time of the procedure
• Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence
• Patient with life expectancy that makes it unlikely 12 months of follow-up will be completed
• Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of the study not pre-approved by Medtronic
• Known allergies or hypersensitivities to adhesives
• Unwilling or unable to comply fully with study procedures and follow-up
• Unable to provide own informed consent