A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE PRO Software in Participants With PsAF

Exclusion Criteria34

• Continuous AF greater than (>) 12 months (1-Year) (Longstanding Persistent AF)
• Previous surgical or catheter ablation for atrial fibrillation
• Any cardiac surgery within the past 2 months (60 days prior to consent date) (includes percutaneous coronary intervention \[PCI\])
• Previous coronary artery bypass grafting (CABG) in conjunction with valvular surgery, cardiac surgery (for example, ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure
• Any carotid stenting or endarterectomy
• Presence of left atrium (LA) thrombus
• Severe dilatation of the LA (left atrial diameter (LAD) > 50 millimeter \[mm\] antero-posterior diameter in case of transthoracic echocardiography \[TTE\])
• Severely compromised left ventricular ejection fraction (LVEF less than \[<\] 40%)
• Known significant pulmonary vein (PV) anomaly that in the opinion of the investigator would preclude enrollment in this study
• Prior diagnosis of pulmonary vein stenosis
• Pre-existing hemi diaphragmatic paralysis
• History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
• MI within the past 2 months (60 days prior to consent date)
• Documented thromboembolic event (including transient ischemic attack \[TIA\]) within the past 6 months (180 days prior to consent date)
• Rheumatic Heart Disease
• Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV
• Severe mitral regurgitation
• Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months
• Unstable angina pectoris within the past 6 months prior to consent date
• Acute illness or active systemic infection or sepsis
• Previously known AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, documented obstructive sleep apnea, acute alcohol toxicity, morbid obesity (Body Mass Index >40 kilogram per meter squared \[kg/m\^2\]), renal insufficiency (with an estimated creatinine clearance < 30 mL/min/1.73 m\^2)
• Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch, prosthetic valve or other abnormality that precludes catheter introduction or manipulation
• Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter
• Presence of any other condition that precludes appropriate vascular access (such as Inferior Vena Cava \[IVC\] filter)
• Significant pulmonary disease, (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease \[COPD\]) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms
• Significant congenital anomaly or medical problems that in the opinion of the investigator would preclude enrollment in this study
• Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation.
• Current enrollment in an investigational study evaluating another device, biologic, or drug
• Presenting contra-indications for the devices used in the study, as indicated in the respective instruction for use (IFU)
• Categorized as vulnerable population and requiring special treatment with respect to safeguards of well-being
• Life expectancy less than 12 months
• Contraindication for MRI such as use of contrast agents due to advanced renal disease, claustrophobia etc. (at PI discretion)
• Presence of iron-containing metal fragments in the body
• Unresolved pre-existing neurological deficit