Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.

The objective of this clinical investigation is to assess the safety and acute effectiveness of the multi-electrode radiofrequency balloon catheter and multi-electrode circular diagnostic catheter when used for the isolation of the pulmonary veins in the treatment of Paroxysmal Atrial Fibrillation (PAF).

Inclusion criteria

• Diagnosed with Symptomatic Paroxysmal AF.
• Selected for atrial fibrillation (AF) ablation procedure for pulmonary vein isolation.
• Able and willing to comply with uninterrupted per-protocol anticoagulation requirements
• Age 18-75 years.
• Able and willing to comply with all pre-, post- and follow-up testing and requirements.
• Signed Patient Informed Consent Form.

Exclusion criteria

• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
• Previous surgical or catheter ablation for AF.
• Anticipated to receive ablation outside the PV ostia and Cavo-triscuspid-isthmus (CTI) region
• Previously diagnosed with persistent, longstanding AF and/or continuous AF > 7 days, or > 48 hrs terminated by cardioversion.
• Any percutaneous coronary intervention (PCI) within the past 2 months.
• Valve repair or replacement and presence of a prosthetic valve.
• Any carotid stenting or endarterectomy.
• Coronary artery bypass grafting (CABG), cardiac surgery (e.g. ventriculotomy, atriotomy), or valvular cardiac surgical or percutaneous procedure within the past 6 months.
• Documented left atrium (LA) thrombus on baseline/pre-procedure imaging.
• LA antero posterior diameter > 50 mm
• Any PV with a diameter ≥ 26 mm
• Left Ventricular Ejection Fraction (LVEF) < 40%.
• Contraindication to anticoagulation (e.g. heparin).
• History of blood clotting or bleeding abnormalities.
• Myocardial infarction within the past 2 months.
• Documented thromboembolic event [including transient ischemic attack(TIA)] within the past 12 months.
• Rheumatic Heart Disease.
• Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV.
• Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.
• Unstable angina.
• Acute illness or active systemic infection or sepsis.
• Diagnosed atrial myxoma or interatrial baffle or patch.
• Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD).
• Significant pulmonary disease, (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.
• Significant congenital anomaly or medical problem 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 child bearing age and plan on becoming pregnant during the course of the clinical investigation.
• Enrollment in an investigational study evaluating another device, biologic, or drug.
• Has known pulmonary vein stenosis.
• Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter.
• Presence of an Inferior Vena Cava (IVC) filter
• Presence of a condition that precludes vascular access.
• Life expectancy or other disease processes likely to limit survival to less than 12 months.
• Presenting contra-indication for the devices (e.g. transthoracic echocardiography (TTE), CT, etc.) used in the study, as indicated in the respective instructions for use.
• Categorized as a vulnerable population and requires special treatment with respect to safeguards of well-being

Additional exclusion criteria for Neurological Assessment Evaluable (NAE) subjects:

• Contraindication to use of contrast agents for MRI such as advanced renal disease, etc. (at PI discretion)
• Presence of iron-containing metal fragments in the body
• Unresolved pre-existing neurological deficit.