Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.
Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.
This clinical investigation is a prospective, multicenter, single arm clinical evaluation
 utilizing the multi-electrode radiofrequency balloon catheter and the multi-electrode
 circular diagnostic catheter.
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:

 1. Diagnosed with Symptomatic Paroxysmal AF.

 2. Selected for atrial fibrillation (AF) ablation procedure for pulmonary vein isolation.

 3. Able and willing to comply with uninterrupted per-protocol anticoagulation
 requirements

 4. Age 18-75 years.

 5. Able and willing to comply with all pre-, post- and follow-up testing and
 requirements.

 6. Signed Patient Informed Consent Form.

 Exclusion Criteria:

 1. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac
 cause.

 2. Previous surgical or catheter ablation for AF.

 3. Anticipated to receive ablation outside the PV ostia and Cavo-triscuspid-isthmus (CTI)
 region

 4. Previously diagnosed with persistent, longstanding AF and/or continuous AF > 7 days,
 or > 48 hrs terminated by cardioversion.

 5. Any percutaneous coronary intervention (PCI) within the past 2 months.

 6. Valve repair or replacement and presence of a prosthetic valve.

 7. Any carotid stenting or endarterectomy.

 8. Coronary artery bypass grafting (CABG), cardiac surgery (e.g. ventriculotomy,
 atriotomy), or valvular cardiac surgical or percutaneous procedure within the past 6
 months.

 9. Documented left atrium (LA) thrombus on baseline/pre-procedure imaging.

 10. LA antero posterior diameter > 50 mm

 11. Any PV with a diameter ≥ 26 mm

 12. Left Ventricular Ejection Fraction (LVEF) < 40%.

 13. Contraindication to anticoagulation (e.g. heparin).

 14. History of blood clotting or bleeding abnormalities.

 15. Myocardial infarction within the past 2 months.

 16. Documented thromboembolic event [including transient ischemic attack(TIA)] within the
 past 12 months.

 17. Rheumatic Heart Disease.

 18. Uncontrolled heart failure or New York Heart Association (NYHA) function class III or
 IV.

 19. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.

 20. Unstable angina.

 21. Acute illness or active systemic infection or sepsis.

 22. Diagnosed atrial myxoma or interatrial baffle or patch.

 23. Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD).

 24. 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.

 25. Significant congenital anomaly or medical problem that, in the opinion of the
 investigator, would preclude enrollment in this study.

 26. 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.

 27. Enrollment in an investigational study evaluating another device, biologic, or drug.

 28. Has known pulmonary vein stenosis.

 29. Presence of intramural thrombus, tumor or other abnormality that precludes vascular
 access, or manipulation of the catheter.

 30. Presence of an Inferior Vena Cava (IVC) filter

 31. Presence of a condition that precludes vascular access.

 32. Life expectancy or other disease processes likely to limit survival to less than 12
 months.

 33. 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.

 34. 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:

 35. Contraindication to use of contrast agents for MRI such as advanced renal disease,
 etc. (at PI discretion)

 36. Presence of iron-containing metal fragments in the body

 37. Unresolved pre-existing neurological deficit.