ARIADNE Clinical Trial

Eligibility Criteria

• 1. Symptomatic PerAF documented by
• 2. . Suitable candidate for catheter ablation.
• 3. . Adults aged 18 - 80 years.
• 4. . Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.
• 1. AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or other reversible or non-cardiac cause.
• 2. Previous left atrial ablation or surgical procedure (including septal closure or left atrial appendage closure).
• 3. Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
• 4. Any carotid stenting or endarterectomy.
• 5. Any cardiac procedure (surgical or percutaneous) or percutaneous coronary intervention within the 90 days prior to the initial procedure.
• 6. Coronary artery bypass graft (CABG) procedure within the 6 months prior to the initial procedure.
• 7. Awaiting cardiac transplantation or other cardiac surgery within the 12 months following the initial ablation procedure.
• 8. Documented thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the initial ablation procedure.
• 9. Documented left atrial thrombus on imaging.
• 10. History of blood clotting or bleeding abnormalities.
• 11. Any condition contraindicating chronic anticoagulation.
• 12. Myocardial infarction (MI) within the 3 months (90 days) prior to the initial procedure.
• 13. Body mass index \>40 kg/m2.
• 14. Left atrial diameter \>55 mm (anterioposterior).
• 15. Diagnosed atrial myxoma.
• 16. Uncontrolled heart failure or NYHA Class III or IV heart failure.
• 17. Rheumatic heart disease.
• 18. Hypertrophic cardiomyopathy.
• 19. Unstable angina.
• 20. Moderate to severe mitral valve stenosis.
• 21. Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2).
• 22. Primary pulmonary hypertension.
• 23. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.
• 24. Renal failure requiring dialysis.
• 25. History of severe Gastroesophageal Reflux Disease (GERD) requiring surgical and/or mechanical intervention.
• 26. Acute illness, active systemic infection, or sepsis.
• 27. Contraindication to both computed tomography and magnetic resonance angiography.
• 28. Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would impact the scientific soundness of the clinical study results.
• 29. Current or anticipated participation in any other clinical study of a drug, device, or biologic during the duration of the study not pre-approved by the Sponsor.
• 30. Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation.
• 31. Known drug or alcohol dependency.
• 32. Life expectancy less than 12 months.