Subcostal Temporary Extravascular Pacing V Study

The STEP V Study is a prospective, multicenter, acute (in-hospital), single-arm feasibility study. The objective of the study is to evaluate the early safety and performance of the latest AtaCor EV Temporary Pacing Lead System over a two-day use period with Subjects restricted to bedrest. Lead performance will also be evaluated without bedrest restrictions in the limited period shortly before lead removal on the last follow-up day.

Inclusion criteriaAt least 18 years oldSubjects indicated for closed-chest cardiac invasive procedure, including: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 or revisionExclusion 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-up (e.g., inability to perform a short walk with the Holter monitor)Participation 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