Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation

Boston Scientific Corporation8 sites in 4 countries55 target enrollmentDecember 2008

ConditionsACC/AHA/NASPE Class 1, IIa or IIb Indications

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: ACC/AHA/NASPE Class 1, IIa or IIb Indications
Sponsor: Boston Scientific Corporation
Enrollment: 55
Locations: 8
Primary Endpoint: Conversion of Induced Ventricular Fibrillation
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective is to evaluate the S-ICD system's ability to identify and terminate induced ventricular fibrillation in patients during the implant procedure. The safety and performance of the S-ICD system will also be assessed throughout the patient follow-up period.

Registry

clinicaltrials.gov

Start Date

December 2008

End Date

August 2009

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Boston Scientific Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Replacement of an existing implanted transvenous ICD system
•Class I, Class IIa, or Class IIb ACC/AHA/HRS indications for patients without an existing transvenous ICD system
•Age is \>= 18 years
•Appropriate pre-operative ECG as measured with a specially developed template

Exclusion Criteria

•Subjects unable or unwilling to provide informed consent
•Any condition which precludes the subject's ability to comply with the study requirements
•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 the S-ICD system trial without written consent from the sponsor.
•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
•Patients with impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) with a GFR \<= 29.