Subcostal Temporary Extravascular Pacing V Study

You may not qualify if:

• BMI ≥ 35 kg/m2
• Septic shock
• Severe anemia
• Patients on dual antiplatelet therapy or anti-coagulation that cannot be stopped for the procedure
• Circumstances 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 Sponsor
• Inability or unwillingness to provide informed consent to participate in the Study
• Known prior history for any of the following:
• Median or partial sternotomy
• Acute coronary syndrome within past 90 days
• NYHA Functional Classification IV within past 90 days
• Surgically 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 silicone
• Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium, including adhesions
• Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)
• +5 more criteria