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

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:	Observational Model: Cohort Time Perspective: Prospective
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: catecholaminergic polymorphic ventricular tachycardia

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
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

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
Sampling Method:	Non-Probability Sample

Study Population

patients requiring ICD therapy

Criteria

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

Contacts and Locations

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

Locations

United Kingdom
Papworth Hospital NHS Trust
Papworth Everard, Cambridge, United Kingdom, CB3 8RE

Sponsors and Collaborators

Cameron Health, Inc.

Investigators

Principal Investigator:

Andrew A Grace, MD, PhD

Papworth Hospital

More Information

No publications provided by Cameron Health, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bardy GH, Smith WM, Hood MA, Crozier IG, Melton IC, Jordaens L, Theuns D, Park RE, Wright DJ, Connelly DT, Fynn SP, Murgatroyd FD, Sperzel J, Neuzner J, Spitzer SG, Ardashev AV, Oduro A, Boersma L, Maass AH, Van Gelder IC, Wilde AA, van Dessel PF, Knops RE, Barr CS, Lupo P, Cappato R, Grace AA. An entirely subcutaneous implantable cardioverter-defibrillator. N Engl J Med. 2010 Jul 1;363(1):36-44. Epub 2010 May 12.

Responsible Party:	Stephen O'Connor, Cameron Health, Inc.
ClinicalTrials.gov Identifier:	NCT00399217 History of Changes
Other Study ID Numbers:	DN-05290
Study First Received:	November 10, 2006
Last Updated:	May 18, 2010
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Cameron Health, Inc.:

subcutaneous ICD
ICD
DFT
Pacing threshold
Polarity

Additional relevant MeSH terms:

Tachycardia
Ventricular Fibrillation
Tachycardia, Ventricular
Arrhythmias, Cardiac

Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013