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Clinical Trials/NCT01117792
NCT01117792CompletedNot Applicable

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

Boston Scientific Corporation16 sites in 4 countries55 target enrollmentStarted: December 2008Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
55
Locations
16
Primary Endpoint
Conversion of Induced Ventricular Fibrillation
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Conversion of Induced Ventricular Fibrillation

Time Frame: Testing done during the implant procedure

The total number of subjects the S-ICD System was successful at converting induced sustained ventricular fibrillation.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (16)

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