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S-ICD® System IDE Clinical Study

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: NCT01064076
Recruitment Status : Completed
First Posted : February 8, 2010
Results First Posted : March 27, 2017
Last Update Posted : March 27, 2017
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
This clinical study is designed to evaluate the safety and effectiveness of the subcutaneous implantable defibrillator (S-ICD) System.

Condition or disease Intervention/treatment Phase
Tachycardia, Ventricular Device: S-ICD System Not Applicable

Detailed Description:

This clinical study is a prospective, non-randomized, multicenter clinical study without a control group conducted in the United States, Europe, and New Zealand.

Patients meeting eligibility criteria for implanting an S-ICD System will be enrolled in this clinical study, implanted with an S-ICD System, and followed prior to hospital discharge, and post-implant at 30 days, 90 days, and 180 days. After the 180-day post-implant follow-up visit, patients will continue to be followed semi-annually until study closure.

Eligible patients enrolled in this clinical study may also participate in the chronic conversion sub-study.

The safety endpoint will be evaluated through the use of a 180-day S-ICD System complication-free rate. The effectiveness endpoint will be evaluated using an induced ventricular fibrillation (VF) conversion efficacy rate. Spontaneous episodes and chronic conversion testing data will be evaluated using descriptive statistics to provide additional data supporting the continued chronic performance of the S-ICD System.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: S-ICD® System Clinical Investigation
Study Start Date : January 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: S-ICD System
This is a single arm study
Device: S-ICD System
The S-ICD System is an implantable technology that uses a subcutaneous pulse generator and subcutaneous electrode system to treat ventricular tachyarrhythmias. The S-ICD System consists of the SQ-RX pulse generator (Model 1010), the Q-TRAK subcutaneous electrode (Model 3010), the Q-TECH programmer (Model 2020), and Q-GUIDE electrode insertion tools (Models 4010 and 4020).
Other Names:
  • SQ-RX Pulse Generator
  • Q-TRAK Subcutaneous Electrode
  • Q-GUIDE Electrode Insertion Tools
  • Q-TECH Programmer

Primary Outcome Measures :
  1. Percentage of Participants Free of Type I Complications at 180 Days. [ Time Frame: 180 days ]
    Percentage of Participants Free of Type I Complications at 180 days compared to the performance goal of 79%. Type I complications are those caused by the S-ICD System.

  2. Percentage of Participants Who Pass Induced VF Conversion Test [ Time Frame: Implant/Pre-Discharge ]
    Percentage of participants who pass induced VF conversion test was compared to a performance goal of 88%. Definition of a success was two consecutive successful 65 joule shocks out of four attempts in the same polarity.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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:

  • For patients without an existing transvenous device

    • Patient meets Class I, Class IIa or Class IIb indications/recommendations for ICD implantation per the current published guidelines at the time of enrollment

  • For patients with an existing transvenous device

    • Patient requires replacement or revision of an existing implanted transvenous ICD system

  • Age is ≥ 18 years
  • An appropriate pre-operative ECG per template provided

Exclusion Criteria:

  • Any condition which precludes the subject's ability to comply with the study requirements, including completion of the study.
  • 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 any other investigational study without prior written consent from the study 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, unless the patient is not a candidate for a transvenous ICD system.
  • Patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant.
  • Patients with unipolar pacemakers or implanted devices that revert to unipolar pacing.
  • Patients with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) with an estimated 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): NCT01064076

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Sponsors and Collaborators
Boston Scientific Corporation
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Study Director: Michael Husby, M.S., MPH Cameron Health, Inc. a Subsidiary of Boston Scientific
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Boston Scientific Corporation Identifier: NCT01064076    
Other Study ID Numbers: DN-03909
First Posted: February 8, 2010    Key Record Dates
Results First Posted: March 27, 2017
Last Update Posted: March 27, 2017
Last Verified: July 2015
Keywords provided by Boston Scientific Corporation:
ICD, defibrillator
Additional relevant MeSH terms:
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Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes