EnSiteTM HD Grid Catheter Mapping System for Advanced High Density (HD) Three-Dimensional Mapping in Non-Paroxysmal Atrial Fibrillation and Atrial Tachycardi - EnSite HD Grid Catheter AF/AT Mapping Study

St. Jude Medical0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•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

•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 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

发起方