Subcutaneous Implantable Defibrillator (S-ICD) System

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-08-31

Brief Summary

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The primary objective is to evaluate the S-ICD system's ability to identify and terminate induced ventricular fibrillation in patients during the implant procedure. The safety and performance of the S-ICD system will also be assessed throughout the patient follow-up period.

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Detailed Description

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Conditions

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ACC/AHA/NASPE Class 1, IIa or IIb Indications

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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S-ICD System

Group Type EXPERIMENTAL

subcutaneous implantable defibrillator (S-ICD) system

Intervention Type DEVICE

implantable defibrillator system

Interventions

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subcutaneous implantable defibrillator (S-ICD) system

implantable defibrillator system

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Replacement of an existing implanted transvenous ICD system
* Class I, Class IIa, or Class IIb ACC/AHA/HRS indications for patients without an existing transvenous ICD system
* Age is \>= 18 years
* Appropriate pre-operative 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 VT that is reliably terminated with anti-tachycardia pacing
* Patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant
* Patients with impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) with a GFR \<= 29.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No