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

NCT01117792 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2021-07-02

Study results available
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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.

Conditions

  • ACC/AHA/NASPE Class 1, IIa or IIb Indications

Interventions

DEVICE

subcutaneous implantable defibrillator (S-ICD) system

implantable defibrillator system

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Stephen O'Connor, PhD, Hon FRCP · Boston Scientific Corporation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-03-31
Completion
2009-08-31

Countries

  • Italy
  • Netherlands
  • New Zealand
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01117792 on ClinicalTrials.gov