A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF

Summary

The main purpose of this clinical study is to investigate the effectiveness workflow of the clinical use of the pulsed field (PF) ablation system (VARIPULSE™ Catheter and TRUPULSE™ Generator) when used for cardiac ablation with the new VARIPULSE™ Pro software in participants with paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and stop on their own, usually within seven days) and persistent atrial fibrillation (PsAF; irregular, rapid heartbeat that lasts over 7 days up to 1year and doesn't stop on its own).

Eligibility

Inclusion criteria:

* Diagnosed with symptomatic persistent atrial fibrillation (PsAF) or paroxysmal atrial fibrillation (PAF)
* Selected to undergo an ablation procedure for management of their arrhythmia by pulmonary vein isolation (PVI) only or PVI only with cavotricuspid isthmus (CTI) dependent atrial flutter ablation
* Failed at least one antiarrhythmic drug (AAD; class I to IV) as evidenced by recurrent symptomatic atrial fibrillation (AF), or intolerable or contraindicated to the AAD
* Age 18-75 years
* Willing and capable of providing consent
* Able and willing to comply with all pre-, post- and follow-up testing and requirements

Exclusion criteria:

* 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 millimeters \[mm\] antero-posterior diameter in case of transthoracic echocardiography \[TTE\])
* Severely compromised left ventricular ejection fraction (LVEF less than \[\<\] 40 percent \[%\])
* 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)
* Myocardial infarction (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 \[Body Mass Index \>40 kilogram per meter square {kg/m\^2}\], renal insufficiency (with an estimated creatinine clearance \< 30 milliliters per minute {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 instructions 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, implantable pacemakers, implantable cardioverter/defibrillators (ICDs),etc. (at principal investigator \[PI\] discretion)
* Presence of iron-containing metal fragments in the body
* Unresolved pre-existing neurological deficit

Conditions2

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