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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-09-30

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.

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Detailed Description

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Conditions

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Ventricular Tachyarrhythmias

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Subcutaneous implantable cardioverter defibrillator (S-ICD) System

Single-arm with 6 patients implanted with an S-ICD System

Group Type EXPERIMENTAL

Subcutaneous Implantable Defibrillator (S-ICD) System

Intervention Type DEVICE

Interventions

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Subcutaneous Implantable Defibrillator (S-ICD) System

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No