Acute Feasibility Investigation of a New S-ICD Electrode

Study Overview
=================
Brief Summary
-----------------
This is an early-stage feasibility study. This study seeks to characterize the performance of the new electrode shock configuration with the S-ICD

Official Title
-----------------
Acute Feasibility Investigation of a New S-ICD Electrode Arrangement for Reduction of Defibrillation Energies

Conditions
-----------------
Ventricular Fibrillation

Intervention / Treatment
-----------------
* Device: commercially released subcutaneous implantable cardioverter defibrillator (S-ICD) and the Investigational S-ICD Adapter.


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Subject is scheduled to receive a de novo S-ICD system implant per labeled indication. Passing S-ICD screening ECG performed per applicable user's manual. Subject is willing and capable of providing informed consent specific to local and national laws. Subject is age 18 or above, or of legal age to give informed consentspecific to local and national law. Key Exclusion Criteria: Subject has an unusual chest anatomy (eg. pectus excavatum and pectus carinatum) that might impede the ability to temporarily insert a second S-ICD electrode. Subject has a left ventricular ejection fraction ≤ 20% within 3 months prior to enrollment. Subject has NYHA Class IV or unstable Class III heart failure. Subject that, in the opinion of the investigator, cannot tolerate the DFT testing required by this protocol. Subject is morbidly obese, defined as BMI ≥ 35. Subject has an active infection or has been treated for infection within the past 30 days. Subject that, in the opinion of the investigator, has an increased risk of infection. Subject is currently requiring/receiving dialysis. Subject has insulin-dependent diabetes. Subject had/has any prior or planned other surgical procedure within ±30 days of enrollment. Subject that, in the opinion of the investigator, has an increased risk for thromboembolic event. Subject that, in the opinion of the investigator, has an increased risk of excessive bleeding. Subject is currently on an active heart transplant list.

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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>Defibrillation threshold (DFT) testing Arm | Device: commercially released subcutaneous implantable cardioverter defibrillator (S-ICD) and the Investigational S-ICD Adapter.<br>* The S-ICD System is a Subcutaneous (under the skin) Implantable Cardioverter Defibrillator for people who are at risk of Sudden Cardiac Arrest. A new electrode configuration will be tested for Defibrillation testing ( DFT). The unit of measure will be in Joules. VF will be induced and the device will deliver a shock at a certain defined energy level as described in the protocol<br>* Other names: The S-ICD System is a Subcutaneous (under the skin) Implantable Cardioverter Defibrillator for people who are at risk of Sudden Cardiac Arrest;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure defibrillation threshold defibrillation threshold (DFT) of the new shock electrode configuration in Joules | The primary objective of this acute feasibility study is to measure the defibrillation threshold (DFT) of the new shock electrode configuration with an S-ICD system.The unit of measure will be in Joules. VF will be induced and the device will deliver a shock at a certain defined energy level as described in the protocol | Acute- During the implant procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversion succes of the new electrode configuration | The secondary objective is to assess the conversion success of the new electrode configuration to convert VF. The unit of measure will be in Joules. VF will be induced and the device will deliver a shock at a certain defined energy level as described in the protocol | Acute- During the implant procedure |