Extravascular ICD Pilot Study

Inclusion Criteria

• Patient has a Class I or IIa indication for implantation of an ICD according to the ACC/AHA/HRS Guidelines[1]
• Patient is willing and able to sign and date the Informed Consent Form.
• Patient is at least 18 years of age and meets age requirements per local law
• Patient is geographically stable and willing and able to comply with the study procedures and visits for the duration of the follow-up

[1] Al-Khatib SM, Stevenson WG, Ackerman MJ, Bryant WJ, Callans DJ, Curtis AB, Deal BJ, Dickfeld T, Field ME, Fonarow GC, Gillis AM, Hlatky MA, Granger CB, Hammill SC, Joglar JA, Kay GN, Matlock DD, Myerburg RJ, Page RL. 2017 AHA/ACC/HRS guideline for management of patients with ventricular arrhythmias

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Exclusion Criteria

• Patient has indications for bradycardia pacing [1] or Cardiac Resynchronization Therapy (CRT) [2] (Class I, IIa, or IIb indication)
• Patient has an existing or had a prior pacemaker, ICD, or CRT device implant or leads
• Patient has anatomical abnormality that significantly increases implant risk[3] including:
• Severe obesity [4]
• Marked RV dilation
• Marked sternal abnormality
• Hiatus hernia that distorts mediastinal anatomy
• Patient has prior chest radiotherapy
• Patient had previous mediastinitis
• Patient had previous coronary artery bypass grafting procedure
• Patient has existing transcatheter aortic valve replacement
• Patient has gastrostomy tube
• Patient has had a prior sternotomy, prior mediastinal instrumentation, prior abdominal surgery in the epigastric region, or planned sternotomy
• Patient has previous pericarditis that:
• Was chronic and recurrent, or
• Resulted in pericardial effusion [5], or
• Resulted in pericardial thickening or calcification [6]
• Patients with a medical condition that precludes them from undergoing defibrillation testing, such as:
• known LV thrombus
• decompensated heart failure
• LVEF 40 [5] As documented on echo or MRI [6] As documented on CT scan or MRI [7] Most recent LVEF in the last 180 days (inclusive) [8] Per physician discretion [9] if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to EV ICD Pilot Study procedures

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