Outcomes of an Optimized Workflow With PulseSelect Pulsed Field Ablation (PFA) System in Paroxysmal and Persistent Atrial Fibrillation

This study will include subjects with a diagnosis of recurrent symptomatic Paroxysmal and Persistent AF. Following the index ablation procedure and hospital discharge, all study subjects will be followed at 7 days, 2 months, 6 months, and 12 months and will be exited from the study at the conclusion of the 12-month follow-up visit.

Inclusion criteria

• Adults who are ≥18 and ≤80 years of age on the day of enrollment (or older than 18 if required by local law)
• A diagnosis of recurrent symptomatic paroxysmal or persistent AF:

Symptomatic paroxysmal AF: 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 12 months prior to enrollment; AND
• at least 1 ECG documented AF episode from any form of rhythm monitoring within 12 months prior to enrollment.

Symptomatic persistent AF: 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 12 months prior to enrollment; AND
• any 24-hour continuous ECG recording documenting continuous AF within 12 months prior to enrollment; OR 2 ECGs from any form of rhythm monitoring taken at least 7 days apart, both showing continuous AF within 12 months prior to enrollment
• Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.

Exclusion criteria

• Long-standing persistent AF (continuous AF that is sustained >12 months)
• Paroxysmal AF patients: AF that required three (3) or more distinct cardioversions in the preceding 12 months.
• Paroxysmal AF: LA anteroposterior diameter > 5.0 cm (by MRI, CT, or TTE) Persistent AF: LA anteroposterior diameter > 5.5 cm (by MRI, CT, or TTE)
• Any of the following procedures, implants, or conditions at baseline: prior left atrial catheter or surgical ablation, prior left atrial percutaneous interventions including left atrial appendage occlusion, and septal closure devices
• 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
• 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)
• Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure
• Contraindication to or unwillingness to use systemic anticoagulation
• Presence of any pulmonary vein stents
• Known pre-existing pulmonary vein stenosis
• Prior valvular (surgical or percutaneous) procedure including prosthetic, bioprosthetic, valve replacement, valve repair or valvuloplasty, and any prior atriotomy
• Moderate to severe mitral valve or aortic stenosis
• Moderate to severe 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 40% measure by acceptable cardiac testing (e.g. TTE), or planned transplant or left ventricular assist device (LVAD)
• Severe lung disease, primary pulmonary hypertension, or any lung disease abnormal blood gases or requiring supplemental oxygen
• Rheumatic heart disease
• Severe thrombocytosis, thrombocytopenia, or any bleeding or clotting disorder
• Documented left atrial thrombus on imaging
• Active systemic infection or sepsis
• 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
• Carotid stenting or endarterectomy
• 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
• Body mass index > 40 kg/m2
• Atrial myxoma
• Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.
• Renal insufficiency with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, or any history of renal failure requiring dialysis or renal transplant
• Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
• Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation
• Known drug or alcohol dependency
• Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would impact the scientific soundness of the clinical trial results
• Amyloid heart disease (cardiac amyloidosis)