EnSite™ HD Grid Catheter AF/AT Mapping Study

This is an interventional diagnostic trial for Non-paroxysmal Atrial Fibrillation Read More

Inclusion Criteria:

1. Presence of non-paroxysmal atrial fibrillation (AF) or left atrial tachycardia (AT) referred for catheter ablation
2. Age of 18 years of age or older at time of Enrollment
3. On continuous anticoagulation (INR 2-3) for >4 weeks prior to the ablation
4. Able and willing to provide written informed consent to participate in this clinical investigation

Exclusion Criteria:

1. Secondary atrial fibrillation (AF)
2. Presence of a prosthetic valve(s) or hemodynamically significant valvular heart disease as determined by Study Investigator
3. Active systemic infection (e.g. sepsis)
4. Presence of left atrial thrombus (i.e., positive TEE) or myxoma, or interatrial baffle or patch via the transseptal approach
5. Contraindication to systemic anticoagulation (i.e., heparin, warfarin, or a direct thrombin inhibitor)
6. History of cerebrovascular accidents (Stroke, TIA)
7. Previous myocardial infarction, unstable angina pectoris or coronary artery by-pass <180 days at Enrollment or cardiovascular intervention expected in the 180 days post-Enrollment
8. Left atrial size >55mm
9. NYHA (New York Heart Association Classification) functional class III or IV heart failure
10. Left ventricular ejection fraction <35%
11. Uncontrolled Hyperthyroidism
12. Pregnant or of childbearing potential and not using adequate contraceptive methods or nursing
13. Participating in another clinical investigation that may confound the results of this clinical investigation
14. Life expectancy less than 12 months, as determined by Study Investigator
15. Severe clinical condition (e.g. active carcinoma) that, in the opinion of the Study Investigator, excludes the participation in the study