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

Withdrawn

• Conditions: Atrial fibrillation; heart rhythm disorder; 10007521

• Registration Number: NL-OMON45653
• Lead Sponsor: St. Jude Medical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 20

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 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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified