a study for treatment of paroxysmal atrial fibrillation (paf) with the omnypulse catheter and the trupulse generator

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to demonstrate safety and effectiveness of the ablation system (omnypulse bi-directional catheter and trupulse generator) when used for isolation of the atrial pulmonary veins (pvs) in treatment of participants with paroxysmal atrial fibrillation (paf).


Eligibility criteria:
inclusion criteria: * diagnosed with symptomatic paroxysmal atrial fibrillation (paf) defined as as atrial fibrillation (af) that terminates spontaneously or with intervention within 7 days of onset. this paf is considered to be symptomatic if symptoms related to af are experienced by the participant * selected for af ablation procedure by pulmonary vein isolation (pvi) * willing and capable of providing consent * able and willing to comply with all pre-, post- and follow-up testing and requirements exclusion criteria: * previously known af secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (example, documented obstructive sleep apnea, acute alcohol toxicity, morbid obesity \[body mass index greater than {\>} 40 kilograms per meter square {kg/m\^2}\]), renal insufficiency (with an estimated creatinine clearance less than (\<) 30 milliliters per minute per 1.73 meter square \[ml/min/1.73 m\^2\]) * previous left atrium (la) ablation or surgery * participants known to require ablation outside the pv region (example, atrioventricular reentrant tachycardia, atrioventricular nodal re-entry tachycardia, atrial tachycardia, ventricular tachycardia and wolff-parkinson-white) * previously diagnosed with persistent af (\> 7 days in duration) * severe dilatation of the left atrium (la) (left anterior descending artery \[lad\] \>50 millimeter \[mm\] antero-posterior diameter in case of transthoracic echocardiography \[tte\]) * presence of la thrombus * severely compromised left ventricular ejection fraction (left ventricular ejection fraction \[lvef\] \<40 percentage \[%\]) * uncontrolled heart failure or new york heart association (nyha) class iii or iv * history of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran) * history of a documented thromboembolic event (including transient ischemic attack \[tia\]) within the past 6 months * previous percutaneous coronary intervention (pci) / myocardial infarction (mi) within the past 2 months * previous coronary artery bypass grafting (cabg) in conjunction with valvular surgery, cardiac surgery (example, ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure * unstable angina pectoris within the past 6 months * anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months * significant pulmonary disease (example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms * 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 * acute illness, active systemic infection, or sepsis * presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation * severe mitral regurgitation * presence of implanted pacemaker or implantable cardioverter-defibrillator (icd) or other implanted metal cardiac device that may interfere with the pulsed electric field energy * presence of a condition that precludes vascular access (such as inferior vena cava \[ivc\] filter) * significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this study * categorized as vulnerable population and requires special treatment with respect to safeguards of well-being * current enrollment in an investigational study evaluating another device or drug * women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation * life expectancy less than 12 months * presenting contra-indications for the devices used in the study, as indicated in the respective instructions for use (ifu) * known contraindication for magnetic resonance imaging (mri) such as use of contrast agents due to advanced renal disease, claustrophobia etcetra. (at principle investigator \[pi\] discretion) * presence of iron-containing metal fragments in the body * known unresolved pre-existing neurological deficit * known uncontrolled significant gastroesophageal reflux disease (gerd)