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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01117792
Recruitment Status : Completed
First Posted : May 5, 2010
Last Update Posted : February 16, 2017
Information provided by (Responsible Party):
Boston Scientific Corporation

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.

Condition or disease Intervention/treatment Phase
ACC/AHA/NASPE Class 1, IIa or IIb Indications Device: subcutaneous implantable defibrillator (S-ICD) system Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation
Study Start Date : December 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: S-ICD System Device: subcutaneous implantable defibrillator (S-ICD) system
implantable defibrillator system

Primary Outcome Measures :
  1. Conversion of induced ventricular fibrillation [ Time Frame: testing done during the implant procedure ]
    Data was reported at 30 days and 6 months

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01117792

Policlinico San Donato
San Donato Milanese, Italy, 20097
Academisch Medisch Centrum
Amsterdam, Netherlands, 1100 DD
Universitair Medisch Centrum
Groningen, Netherlands, 9713 GZ
St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3435 CM
Erasmus Medical Center
Rotterdam, Netherlands, 3015 GD
New Zealand
Auckland City Hospital
Auckland, New Zealand, 1001
Christchurch Hospital
Christchurch, New Zealand, 8002
United Kingdom
Russells Hall Hospital
Dudley, United Kingdom, DY1 2HQ
Sponsors and Collaborators
Boston Scientific Corporation
Study Director: Stephen O'Connor, PhD, Hon FRCP Boston Scientific Corporation

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Boston Scientific Corporation Identifier: NCT01117792     History of Changes
Other Study ID Numbers: DN-01040
First Posted: May 5, 2010    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: May 2010