Further Acute Research of a Subcutaneous Implantable Defibrillator (S-ICD) System

Study Overview
=================
Brief Summary
-----------------
The purpose is to further evaluate the operation, safety, and feasibility of a subcutaneous implantable defibrillator (S-ICD) system in patients who require an implantable cardioverter defibrillator (ICD)for treating ventricular tachyarrhythmias. The S-ICD electrode and pulse generator emulator will be briefly implanted and tested during the standard implantation procedure of an ICD, but then the S-ICD system will be removed entirely.

Detailed Description
-----------------
The objectives of this study are to further evaluate the S-ICD system's ability to identify and terminate induced ventricular tachyarrhythmias in patients acutely with an S-ICD emulator and parasternal electrode during the implant procedure of a standard transvenous ICD. The active emulator is not a powered medical device and all elements of the test system are removed following the testing. This acute intra-operative protocol will test the ability of the electrode and emulator to appropriately convert the arrhythmia and allos an assessment of post shock pacing.

Official Title
-----------------
Acute Intra-operative Testing of Subcutaneous Implantable Defibrillator Emulator and Parasternal Electrode, Acutely Implanted, for Comparison With Transvenous System

Conditions
-----------------
Ventricular Fibrillation, Ventricular Tachycardia

Intervention / Treatment
-----------------
* Device: Subcutaneous Implantable Defibrillator (S-ICD) system
* Device: ICD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients requiring ICD therapy according to National Centre for Clinical Excellence (NICE) criteria are eligible And patients who require replacement of an existing transvenous ICD system are eligible Exclusion Criteria: Patients unable or unwilling to provide informed consent Any conditions which precludes the subject's ability to comply with the study requirements, including completion of the study Females who are pregnant or lactating and pre-menopausal women who are unwilling to use adequate birth control for the duration of the study Participation in another investigational device trial at any time during the conduct of this study Patients with a serious medical condition and life expectancy of less than one year Patients with documented spontaneous and frequently recurring VT that is reliably terminated with anti-tachycardia pacing Patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Subcutaneous Implantable Defibrillator (S-ICD) system|nan|
|Device: ICD|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
subcutaneous ICD, ICD, DFT, Pacing threshold, Polarity