EnSite™ HD Grid Catheter AF/AT Mapping Study

Launched by ABBOTT MEDICAL DEVICES · Jan 12, 2016

Keywords

ClinConnect Summary

Catheter ablation for non-paroxysmal AF is more complex as triggers, if present at all, are not immediately apparent, but the abnormal atrial substrates are the likely predominant mechanisms. Additional catheter ablation strategies targeting for atrial substrate modification have been introduced. The common strategies involve either application of empirical linear lesion sets in the atrial areas or ablation of atrial areas with complex fractionated atrial electrograms in addition to pulmonary vein isolation. Nevertheless, the corresponding success rates in long-term sinus rhythm maintenance...

Gender

ALL

Eligibility criteria

• 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