S-ICD® System IDE Clinical Study

February 7, 2017 updated by: Boston Scientific Corporation

S-ICD® System Clinical Investigation

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
330

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nieuwegein, Netherlands, 3435 CM
        • St. Antonius Ziekenhuis
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus Medical Center
  • New Zealand
      • Auckland, New Zealand, 1001
        • Auckland City Hospital
      • Christchurch, New Zealand, 8140
        • Christchurch Hospital
  • United Kingdom
    • Cambridge
      • Papworth Everard, Cambridge, United Kingdom, CB3 8RE
        • Papworth Hospital NHS Trust
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Arizona Arrhythmia Consultants
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • Pasadena, California, United States, 91105
        • Foothill Cardiology
      • Redwood City, California, United States, 94062
        • CMCA / Sequoia Hospital
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
      • San Diego, California, United States, 92123
        • Sharp Grossmont Hospital
      • Santa Monica, California, United States, 90404
        • Pacific Heart Institute
      • Torrance, California, United States, 90503
        • South Bay Electrophysiology
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University School Of Medicine
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Oakbrook Terrace, Illinois, United States, 60181
        • Midwest Heart Foundation
    • Indiana
      • Fort Wayne, Indiana, United States, 46805
        • Parkview Research Center
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper University Hospital
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Mid Carolina Cardiology Research
      • Winston-Salem, North Carolina, United States, 27103
        • Forsyth Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of The University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University College of Medicine
    • South Carolina
      • Charleston, South Carolina, United States, 29464
        • Medical University of South Carolina
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital
      • Norfolk, Virginia, United States, 23507
        • Sentara Heart Hospital
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
      • Spokane, Washington, United States, 99204
        • Heart Clinics Northwest
      • Vancouver, Washington, United States, 98684
        • The Vancouver Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
180 days
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.
Implant/Pre-Discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Michael Husby, M.S., MPH, Cameron Health, Inc. a Subsidiary of Boston Scientific

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DN-03909

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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