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NCT00399217 Clinical Trial

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

Ventricular Tachycardia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00399217
Other study ID # DN-05290
Secondary ID
Status Completed
Phase N/A
First received November 10, 2006
Last updated February 14, 2017
Start date November 2006
Est. completion date June 2008

Study information
Verified date May 2010
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 55
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

• ICD

Locations
Country Name City State
United Kingdom Papworth Hospital NHS Trust Papworth Everard Cambridge

Sponsors (1)
Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United Kingdom, 

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