Extravascular ICD Pilot Study

Study Overview
=================
Brief Summary
-----------------
The proposed study is designed to characterize the safety and efficacy of a new extravascular implantable cardioverter defibrillator (ICD) system in humans.

Detailed Description
-----------------
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.

Official Title
-----------------
Extravascular ICD Pilot Study

Conditions
-----------------
Tachycardia, Ventricular Arrythmia

Intervention / Treatment
-----------------
* Device: Defibrillation using the Extravascular ICD


Participation Criteria
=================
Eligibility Criteria
-----------------
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 - 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 <20% [7] other physician discretion 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 Patients with comorbidities which may increase surgical risk of complications[8] including: • severe aortic stenosis COPD and is oxygen dependent Hepatosplenomegaly Marked hepatomegaly Patient is on renal dialysis Patient with any evidence of active infection or undergoing treatment for an infection Patient with current implantation of neurostimulator or any other chronically implanted device which uses current in the body. Patients with a limited life expectancy of less than 12 months 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 Patient with any exclusion criteria as required by local law (e.g., age, pregnancy, breast feeding) 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 -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Patients will be implanted with an extravascular ICD and undergo requisite electrical testing. | Device: Defibrillation using the Extravascular ICD<br>* VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Outcome - Number of Participants That Had Successful Termination of Ventricular Fibrillation Episodes at Implantation | Each subject will demonstrate a successful defibrillation outcome if either 2 successive induced ventricular fibrillation episodes are terminated by the subject's device delivering a shock at the required energy level, or if one such episode is successfully terminated by the subject's device delivering a shock at a lower energy level. Up to 5 such episodes may be induced to test device efficacy. | At Implantation | 
| Safety Outcome - Percentage of Participants With Freedom From Major System and Procedure Related Complications at 3 Months (90 Days) | Subjects will be monitored to determine whether they experience a major procedure- or system-related complication within 3 months (90 days) post-implant. | 3 months (90 days) |