Sensing and Defibrillation With a Commercially Available ICD Coupled With a Parasternal Extravascular Lead (SECURE EV) Study

Exclusion Criteria

• •1. NYHA IV functional class
• •2. BMI ≥ 35 kg/m2
• •3. Inotropic therapy in past 180 days
• •4. Subjects who require continual ventricular pacing
• •5. Presence or planned use of a subcutaneous ICD lead, subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads within the study period.
• •6. Planned MRI within the study period
• •7. Subjects on anticoagulation or antiplatelet therapy that cannot be temporarily discontinued for the procedure
• •8. Logistical or safety related circumstances that may prevent data collection or follow-up
• •9. Participation in any concurrent clinical study without prior written approval from the Sponsor
• •10. Inability to give an informed consent to participate in the Study
• •Known prior history for any of the following:
• •11. Structural abnormalities of the heart that may increase risk of the study procedure or an obstructed/restricted pathway into the mediastinum for the EV-ICD Dilator, EV-ICD Delivery Tool and EV-ICD Lead
• •12. Uncontrolled paroxysmal, persistent or permanent atrial fibrillation
• •13. Median or partial sternotomy
• •14. Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium
• •15. Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)
• •16. Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments/conditions which may complicate the EV-ICD Lead insertion procedure
• •17. Pericardial disease, pericarditis and mediastinitis
• •18. Medical treatments, surgeries or conditions that increase the potential for pericardial adhesions
• •19. FEV1 \< 1.0 Liter
• •20. Surgically corrected congenital heart disease (not including catheter-based procedures)
• •21. Allergies to the device materials as listed in the Instructions for Use (IFU)