Extravascular ICD Pilot Study
Extravascular ICD Pilot Study
The proposed study is designed to characterize the safety and efficacy of a new extravascular
 implantable cardioverter defibrillator (ICD) system in humans.
The study will recruit male and female adult subjects that meet all of the inclusion criteria
 and none of the exclusion criteria. All subjects will be indicated to receive an ICD.

 The EV ICD system will be implanted and the subjects will be followed for at least 3 months
 following implantation of the system.

 Subjects will be exited after follow-up is completed.
Inclusion Criteria:

 1. Patient has a Class I or IIa indication for implantation of an ICD according to the
 ACC/AHA/HRS Guidelines[1]

 2. Patient is willing and able to sign and date the Informed Consent Form.

 3. Patient is at least 18 years of age and meets age requirements per local law

 4. 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:

 1. Patient has indications for bradycardia pacing [1] or Cardiac Resynchronization
 Therapy (CRT) [2] (Class I, IIa, or IIb indication)

 2. Patient has an existing or had a prior pacemaker, ICD, or CRT device implant or leads

 3. 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

 4. Patient has prior chest radiotherapy

 5. Patient had previous mediastinitis

 6. Patient had previous coronary artery bypass grafting procedure

 7. Patient has existing transcatheter aortic valve replacement

 8. Patient has gastrostomy tube

 9. Patient has had a prior sternotomy, prior mediastinal instrumentation, prior abdominal
 surgery in the epigastric region, or planned sternotomy

 10. Patient has previous pericarditis that:

 • Was chronic and recurrent, or

 • Resulted in pericardial effusion [5], or

 • Resulted in pericardial thickening or calcification [6]

 11. Patients with a medical condition that precludes them from undergoing defibrillation
 testing, such as:

 • known LV thrombus

 • decompensated heart failure

 -  LVEF <20% [7]

 -  other physician discretion

 12. Patient has persistent Atrial Fibrillation who is at high risk of a thromboembolic
 event with a CHA₂DS₂-VASc score ≥3, or is contraindicated for having anticoagulation
 interrupted for ≥72 hours

 13. Patients with comorbidities which may increase surgical risk of complications[8]
 including:

 • severe aortic stenosis

 -  COPD and is oxygen dependent

 -  Hepatosplenomegaly

 -  Marked hepatomegaly

 14. Patient is on renal dialysis

 15. Patient with any evidence of active infection or undergoing treatment for an infection

 16. Patient with current implantation of neurostimulator or any other chronically
 implanted device which uses current in the body.

 17. Patients with a limited life expectancy of less than 12 months

 18. Patient is enrolled or planning to enroll in a concurrent drug or device study that
 may confound the results of this study, without documented pre-approval from a
 Medtronic study manager

 19. Patient with any exclusion criteria as required by local law (e.g., age, pregnancy,
 breast feeding)

 20. Pregnant women or breastfeeding women, or women of child bearing potential and who are
 not on a reliable form of birth regulation method or abstinence [9]

 [1] 2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement on optimal implantable
 cardioverter-defibrillator programming and testing).

 [2] ACC/AHA/HRS guidelines for Cardiac Resynchronization Therapy [3] Per physician
 discretion [4] BMI > 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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