Further Acute Research of a Subcutaneous Implantable Defibrillator (S-ICD) System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-06-30

Brief Summary

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The purpose is to further evaluate the operation, safety, and feasibility of a subcutaneous implantable defibrillator (S-ICD) system in patients who require an implantable cardioverter defibrillator (ICD)for treating ventricular tachyarrhythmias. The S-ICD electrode and pulse generator emulator will be briefly implanted and tested during the standard implantation procedure of an ICD, but then the S-ICD system will be removed entirely.

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Detailed Description

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The objectives of this study are to further evaluate the S-ICD system's ability to identify and terminate induced ventricular tachyarrhythmias in patients acutely with an S-ICD emulator and parasternal electrode during the implant procedure of a standard transvenous ICD.

The active emulator is not a powered medical device and all elements of the test system are removed following the testing.

This acute intra-operative protocol will test the ability of the electrode and emulator to appropriately convert the arrhythmia and allos an assessment of post shock pacing.

Conditions

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Ventricular Fibrillation Ventricular Tachycardia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Subcutaneous Implantable Defibrillator (S-ICD) system

Intervention Type DEVICE

ICD

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients requiring ICD therapy according to National Centre for Clinical Excellence (NICE) criteria are eligible
* And patients who require replacement of an existing transvenous ICD system are eligible

Exclusion Criteria

* Patients unable or unwilling to provide informed consent
* Any conditions 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 another investigational device trial at any time during the conduct of this study
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No