Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation

Exclusion Criteria

• •1. Subjects with New York Heart Association (NYHA) Class III or IV heart failure \< 180 days prior to enrollment
• •2. Left atrial diameter \> 5.0 cm or left atrial volume \>50 ml/m² indexed based on the most recent echocardiography+
• •3. Left ventricular ejection fraction \< 35% based on the most recent echocardiogram +
• •4. Continuous AF lasting longer than seven (7) days
• •5. Subjects who have undergone any previous left atrial cardiac ablation (RF, Cryo, surgical)
• •6. Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
• •7. Subjects who have undergone any cardiac ablation or any surgery within 30 days prior to enrollment
• •8. Currently implanted with a pacemaker, ICD, CRT device, or an implanted arrhythmia loop recorder
• •9. Active systemic infection
• •10. Unstable angina or ongoing myocardial ischemia
• •11. Myocardial Infarction (MI) within 90 days prior to enrollment
• •12. Evidence of myxoma, left atrial thrombus or intracardiac mural thrombus++
• •13. Previous cardiac surgery (i.e. ventriculotomy, atriotomy, CABG, PTCA, PCI, coronary stenting procedures) ≤ 90 days prior to enrollment.
• •14. Severe valvular disease, including mechanical prosthetic mitral or tricuspid heart valves (patients with successful mitral valve repair allowed - annular ring constitutes repair);
• •15. Any prior history of documented cerebral infarct, TIA or systemic embolism \[excluding a post-operative deep vein thrombosis (DVT)\] \<180 days prior to enrollment
• •16. Moderate or severe mitral stenosis (severity assessed on the most recent TTE ≤180 days prior to enrollment. Defined as pulmonary artery systolic pressure \>30 mmHg)
• •17. Presence of left atrial appendage closure device
• •18. Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder
• •19. Subjects who, in the judgment of the investigator, have a life expectancy of less than two (2) years
• •20. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon investigator's discretion)
• •21. Amiodarone use within 60 days prior to enrollment
• •22. Any carotid stenting or endarterectomy
• •23. Stage 3B renal disease or higher (estimated glomerular filtration rate, eGFR \<45 mL/min)
• •24. Known coagulopathy disorder (e.g. von Willebrand's disease, hemophilia)
• •25. Any known contraindication to an AF ablation
• •26. Any known contraindication for anticoagulation (e.g. patients unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation)
• •27. Vena cava embolic protection filter devices and/or known femoral thrombus that prevents catheter insertion from the femoral approach
• •28. Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication
• •29. Rheumatic Heart Disease
• •30. Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter
• •31. Subjects unable or unwilling to complete follow-up visits and examinations for the duration of the clinical study
• •32. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the sponsor to determine eligibility.
• •* The absence of thrombus must be confirmed by means of a trans-esophageal echocardiogram (TEE) within 48 hours prior to the procedure or Intracardiac Echography (ICE) during the procedure in subjects not adequately anticoagulated per Section 10.4.2. If a thrombus is observed, the subject no longer meets eligibility criteria and should be considered "Consent Ineligible".