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

Tracking Information

First Received Date ^ICMJE

November 10, 2006

Last Updated Date

November 10, 2006

Start Date ^ICMJE

November 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Acute Intra-Operative Testing of Subcutaneous Implantable Defibrillator Emulator and Parasternal Electrode, Acutely Implanted, for Comparison With Transvenous System

Brief Summary

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.

Detailed Description

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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Screening, Cross-Sectional, Defined Population, Prospective Study

Condition ^ICMJE

Ventricular Fibrillation
Ventricular Tachycardia

Intervention ^ICMJE

Device: Subcutaneous Implantable Defibrillator (S-ICD) system
Device: ICD

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients requiring ICD therapy according to National Centrre 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Andrew A Grace, MD, PhD	+44 1223 333631	Agracesec@aol.com
Contact: Claire Paine	+44 01480 364350	Claire.Paine@papworth.nhs.uk

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00399217

Responsible Party

Study ID Numbers ^ICMJE

DN-05290

Study Sponsor ^ICMJE

Cameron Health, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Andrew A Grace, MD, PhD

Papworth Hospital

Information Provided By

Cameron Health, Inc.

Verification Date

November 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP