Prospective, multi-center, single-arm, early feasibility utilizing a novel radiofrequency ablation catheter

Biosense Webster, Inc.0 sites39 target enrollmentJanuary 30, 2017

Overview

Registry

who.int

Start Date

January 30, 2017

End Date

June 30, 2017

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Symptomatic paroxysmal atrial fibrillation with at least one documented atrial fibrillation episode within one year prior to enrollment
•2\. Failed at least one antiarrhythmic drug (class I or III)
•3\. Pre\-procedural anticoagulation on warfarin, rivaroxaban or apixaban. If receiving warfarin therapy, patients must agree to take warfarin for at least 4 weeks prior to the scheduled ablation procedure.
•4\. Age 18 years or older
•5\. Able and willing to comply with all pre\-, post\- and follow\-up testing and requirements (e.g. Patient not confined by a court ruling)
•6\. Signed Patient Informed Consent Form

•1\. Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non\-cardiac cause
•2\. Previous surgical or catheter ablation for atrial fibrillation
•3\. Previously diagnosed with persistent or longstanding atrial fibrillation
•4\. Any percutaneous coronary intervention (PCI), cardiac surgery, or valvular cardiac surgical or percutaneous procedure (e.g. ventriculotomy, atriotomy) within the past 2 months
•5\. Valve repair or replacement and presence of a prosthetic valve
•6\. Any carotid stenting or endarterectomy
•7\. Coronary artery bypass grafting surgery within the past 6 months
•8\. Documented left atrium thrombus on baseline/pre\-procedure imaging
•9\. LA size \> 55 mm
•10\. Left Ventricular Ejection Fraction (LVEF) \< 40%