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

Sponsor:	Cameron Health, Inc.
Information provided by:	Cameron Health, Inc.
ClinicalTrials.gov Identifier:	NCT00399217

Purpose

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.

Condition	Intervention
Ventricular Fibrillation Ventricular Tachycardia	Device: Subcutaneous Implantable Defibrillator (S-ICD) system Device: ICD

Study Type:	Observational
Study Design:	Screening, Cross-Sectional, Defined Population, Prospective Study
Official Title:	Acute Intra-Operative Testing of Subcutaneous Implantable Defibrillator Emulator and Parasternal Electrode, Acutely Implanted, for Comparison With Transvenous System

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Pacemakers and Implantable Defibrillators

U.S. FDA Resources

Further study details as provided by Cameron Health, Inc.:

Estimated Enrollment:	50
Study Start Date:	November 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00399217

Contacts

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

Locations

United Kingdom, Cambridge
Papworth Hospital NHS Trust	Recruiting
Papworth Everard, Cambridge, United Kingdom, CB3 8RE
Principal Investigator: Andrew A Grace, MD, PhD

Sponsors and Collaborators

Cameron Health, Inc.

Investigators

Principal Investigator:

Andrew A Grace, MD, PhD

Papworth Hospital

More Information

No publications provided

Study ID Numbers:	DN-05290
Study First Received:	November 10, 2006
Last Updated:	November 10, 2006
ClinicalTrials.gov Identifier:	NCT00399217 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Cameron Health, Inc.:

subcutaneous ICD
ICD
DFT
Pacing threshold
Polarity

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Tachycardia
Cardiovascular Diseases

Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on November 22, 2009