S-ICD® System IDE Clinical Study

Not Applicable

Completed

Brief Summary: This clinical study is designed to evaluate the safety and effectiveness of the subcutaneous implantable defibrillator (S-ICD) System.

Detailed Description: This clinical study is a prospective, non-randomized, multicenter clinical study without a control group conducted in the United States, Europe, and New Zealand.

Patients meeting eligibility criteria for implanting an S-ICD System will be enrolled in this clinical study, implanted with an S-ICD System, and followed prior to hospital discharge, and post-implant at 30 days, 90 days, and 180 days. After the 180-day post-implant follow-up visit, patients will continue to be followed semi-annually until study closure.

Eligible patients enrolled in this clinical study may also participate in the chronic conversion sub-study.

The safety endpoint will be evaluated through the use of a 180-day S-ICD System complication-free rate. The effectiveness endpoint will be evaluated using an induced ventricular fibrillation (VF) conversion efficacy rate. Spontaneous episodes and chronic conversion testing data will be evaluated using descriptive statistics to provide additional data supporting the continued chronic performance of the S-ICD System.

Recruitment & Eligibility

Inclusion Criteria

For patients without an existing transvenous device

• Patient meets Class I, Class IIa or Class IIb indications/recommendations for ICD implantation per the current published guidelines at the time of enrollment
For patients with an existing transvenous device

• Patient requires replacement or revision of an existing implanted transvenous ICD system
Age is ≥ 18 years
An appropriate pre-operative ECG per template provided

Exclusion Criteria

Any condition 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 any other investigational study without prior written consent from the study sponsor.
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, unless the patient is not a candidate for a transvenous ICD system.
Patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant.
Patients with unipolar pacemakers or implanted devices that revert to unipolar pacing.
Patients with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) with an estimated GFR ≤ 29.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Free of Type I Complications at 180 Days.	180 days	Percentage of Participants Free of Type I Complications at 180 days compared to the performance goal of 79%. Type I complications are those caused by the S-ICD System.
Percentage of Participants Who Pass Induced VF Conversion Test	Implant/Pre-Discharge	Percentage of participants who pass induced VF conversion test was compared to a performance goal of 88%. Definition of a success was two consecutive successful 65 joule shocks out of four attempts in the same polarity.

Secondary Outcome Measures

Name	Time	Method

Locations (33): Arizona Arrhythmia Consultants
🇺🇸
Scottsdale, Arizona, United States
University of Southern California
🇺🇸
Los Angeles, California, United States
Foothill Cardiology
🇺🇸
Pasadena, California, United States
CMCA / Sequoia Hospital
🇺🇸
Redwood City, California, United States
Sharp Grossmont Hospital
🇺🇸
San Diego, California, United States
Sharp Memorial Hospital
🇺🇸
San Diego, California, United States
Pacific Heart Institute
🇺🇸
Santa Monica, California, United States
South Bay Electrophysiology
🇺🇸
Torrance, California, United States
Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
Emory University School of Medicine
🇺🇸
Atlanta, Georgia, United States
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Arizona Arrhythmia Consultants
🇺🇸Scottsdale, Arizona, United States