Safety and Preliminary Performance of Xtrac O.S. System for Lead Extraction.

"This is an open label, non-randomized, feasibility, prospective, interventional clinical trial of lead extraction. The Xtrac O.S. system is intended for transvenous removal of pacing or defibrillator leads, having an inner lumen, through a superior approach.~The decision upon lead extraction will be based upon the applicable Heart Rhythm Society guidelines or European Heart Rhythm Association (EHRA).~Each enrolled patient will undergo a pre procedural evaluation to enable planning of the extraction procedure. The evaluation includes an assessment of the CIED components to be removed, dwell time, anatomic course on radiography and patient characteristics that may require management prior to extraction.~A multidisciplinary team evaluation involving cardiac surgery, electrophysiologist, and cardiac anesthesiology should allow for a rapid and successful response to major complications"