Status:
COMPLETED
Further Acute Research of a Subcutaneous Implantable Defibrillator (S-ICD) System
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Ventricular Fibrillation
Ventricular Tachycardia
Eligibility:
All Genders
18+ years
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 (...
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 parasterna...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00399217
Start Date
November 1 2006
End Date
June 1 2008
Last Update
February 16 2017
Active Locations (1)
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1
Papworth Hospital NHS Trust
Papworth Everard, Cambridge, United Kingdom, CB3 8RE