Pilot evaluatIon Of NovEl tEmpoRary ExtraVascular PACING (PIONEER EV PACING) Study

The PIONEER EV PACING Study is prospective, multi-center, acute (in-hospital), single-arm, pilot study. The study objective is to characterize preliminary safety and performance of the AtaCor EV Temporary Pacing Lead System when used as intended for clinical use as a temporary pacing lead.

Inclusion criteriaAt least 18 years oldSubjects who:Are undergoing one of the following planned (non-urgent) procedures that are associated with the potential need for temporary bradycardia pacing:Transarterial transcatheter aortic valve implantation (TAVI)Transarterial balloon aortic valvuloplasty (BAV)Cardiovascular implantable electronic device (CIED) pulse generator replacementCardiovascular implantable electronic device (CIED) lead extraction ORSubjects with bradycardia who are under evaluation to determine if the cause is transient or permanentExclusion criteriaBMI ≥ 35 kg/m2Septic shockSevere anemiaPatients on dual antiplatelet therapy or anti-coagulation that cannot be stopped for the procedureCircumstances that prevent data collection or follow-upParticipation in any concurrent clinical study without prior written approval from the SponsorInability or unwillingness to provide informed consent to participate in the StudyKnown prior history for any of the following:Median or partial sternotomyAcute coronary syndrome within past 90 daysNYHA Functional Classification IV within past 90 daysSurgically corrected congenital heart disease (not including catheter-based procedures)Allergies to the device materials such as stainless steel, titanium, platinum, iridium, polyethylene, polyurethane, polycarbonate and siliconeSurgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium, including adhesionsSignificant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments which may complicate the AtaCor EV Temporary Pacing Lead System insertion procedureAny conditions which may complicate the AtaCor EV Temporary Pacing Lead System insertion procedurePericardial disease, pericarditis and mediastinitisMedical treatments, surgeries or conditions that increase the potential for pericardial adhesionsFEV1 < 1 liter