Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System

Study Overview
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Brief Summary
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Primary objective is to evaluate the safety and performance of the implanted Subcutaneous implantable cardioverter defibrillator (S-ICD) system. A maximum of 10 subjects were to be enrolled and followed for one month to collect data on the safety, efficacy, and performance of the implanted S-ICD system. Additionally, patient comfort will be assessed as will cosmetic outcome.

Official Title
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Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System

Conditions
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Ventricular Tachyarrhythmias

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: replacement of an existing transvenous implantable cardioverter defibrillator (ICD) system American College of Cardiology/American Heart Association/Heart Rhythm Society (ACC/AHA/HRS) Class I or II indications for ICD implantation Age >= 18 years Appropriate pre-operative Electrocardiogram (ECG) as measured with a specially developed template Exclusion Criteria: Subjects unable or unwilling to provide informed consent Any condition which precludes the subject's ability to comply with the study requirements 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 the S-ICD system trial without written consent from the sponsor. Patients with a serious medical condition and life expectancy of less than one year. Patients with documented spontaneous and frequently recurring ventricular tachyarrhythmias (VT) that is reliably terminated with anti-tachycardia pacing Patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant Patients with chronic renal failure, i.e. with a creatinine level of >2.5 mg/dl unless prescribed drug therapy known to increase creatinine levels in which case the value should be <= 3mg/dl

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subcutaneous implantable cardioverter defibrillator (S-ICD) System<br>Single-arm with 6 patients implanted with an S-ICD System | Device: Subcutaneous Implantable Defibrillator (S-ICD) System<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Successful Induced Ventricular Fibrillation Conversion | Sustained ventricular fibrillation induced by the investigator is successfully converted. A successful conversion was defined as two consecutive successful shocks out of four attempts with either standard polarity or with reverse polarity. | 30 days |