Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System

Boston Scientific Corporation2 sites in 1 country6 target enrollmentJuly 2008

ConditionsVentricular Tachyarrhythmias

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ventricular Tachyarrhythmias
Sponsor: Boston Scientific Corporation
Enrollment: 6
Locations: 2
Primary Endpoint: Number of Participants With a Successful Induced Ventricular Fibrillation Conversion
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Primary objective is to evaluate the safety and performance of the implanted Subcutaneous implantable cardioverter defibrillator (S-ICD) system. A maximum of 10 subjects were to be enrolled and followed for one month to collect data on the safety, efficacy, and performance of the implanted S-ICD system. Additionally, patient comfort will be assessed as will cosmetic outcome.

Registry

clinicaltrials.gov

Start Date

July 2008

End Date

September 2008

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 transvenous implantable cardioverter defibrillator (ICD) system
•American College of Cardiology/American Heart Association/Heart Rhythm Society (ACC/AHA/HRS) Class I or II indications for ICD implantation
•Age \>= 18 years
•Appropriate pre-operative Electrocardiogram (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 ventricular tachyarrhythmias (VT) that is reliably terminated with anti-tachycardia pacing
•Patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant
•Patients with chronic renal failure, i.e. with a creatinine level of \>2.5 mg/dl unless prescribed drug therapy known to increase creatinine levels in which case the value should be \<= 3mg/dl

Outcomes

Primary Outcomes

Number of Participants With a Successful Induced Ventricular Fibrillation Conversion

Time Frame: 30 days

Sustained ventricular fibrillation induced by the investigator is successfully converted. A successful conversion was defined as two consecutive successful shocks out of four attempts with either standard polarity or with reverse polarity.