A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator

Korábbi kezelés

• Previous left atrium (LA) ablation or surgery
• Previously diagnosed with persistent AF (> 7 days in duration)
• 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
• Prior diagnosis of pulmonary vein stenosis
• 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

Más betegség

• 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
• 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
• Acute illness, active systemic infection, or sepsis
• 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)
• 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)
• Known uncontrolled significant gastroesophageal reflux disease (GERD)

Laborértékek

• 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])
• Severely compromised left ventricular ejection fraction (left ventricular ejection fraction [LVEF] <40 percentage [%])

Életkor

• 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

Egyéb

• 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)
• 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
• Known significant pulmonary vein (PV) anomaly that in the opinion of the investigator would preclude enrollment in this study
• Pre-existing hemi diaphragmatic paralysis
• Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
• Severe mitral regurgitation
• Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this study
• 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)
• Presence of iron-containing metal fragments in the body
• Known unresolved pre-existing neurological deficit

• 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