Subcostal Temporary Extravascular Pacing IV (STEP IV) Study

Exclusion Criteria

• •1. BMI ≥ 35 kg/m2
• •2. Septic shock
• •3. Severe anemia
• •4. Acute coronary syndrome within past 90 days
• •5. NYHA IV Functional Classification of heart failure within past 90 days
• •6. Circumstances that prevent data collection or follow-up (e.g., inability to perform a short walk with the Holter monitor)
• •7. Participation in any concurrent clinical study without prior written approval from the Sponsor
• •8. Inability or unwillingness to provide informed consent to participate in the Study
• •Known prior history for any of the following:
• •9. Median or partial sternotomy
• •10. Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium
• •11. Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)
• •12. Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments/conditions which may complicate the AtaCor EV Temporary Pacing Lead System insertion procedure
• •13. Pericardial disease, pericarditis and mediastinitis
• •14. Medical treatments, surgeries or conditions that increase the potential for pericardial adhesions
• •15. FEV1 \< 1 liter
• •16. Surgically corrected congenital heart disease (not including catheter-based procedures)
• •17. Allergies to the device materials such as stainless steel, titanium, platinum, iridium, polyethylene, polyurethane, polycarbonate, and silicone