S-ICD® System IDE Clinical Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cameron Health, Inc.
ClinicalTrials.gov Identifier:
NCT01064076
First received: February 4, 2010
Last updated: October 8, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention
Tachycardia, Ventricular
Device: S-ICD System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: S-ICD® System Clinical Investigation

Resource links provided by NLM:


Further study details as provided by Cameron Health, Inc.:

Primary Outcome Measures:
  • Safety: The 180-day S-ICD System complication-free rate meets or exceeds the performance goal of 79%. [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
  • Effectiveness: The induced VF conversion efficacy rate meets or exceeds the performance goal of 88%. [ Time Frame: Implant/Pre-Discharge ] [ Designated as safety issue: No ]

Enrollment: 330
Study Start Date: January 2010
Estimated Study Completion Date: October 2013
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01064076

  Hide Study Locations
Locations
United States, Arizona
Arizona Arrhythmia Consultants
Scottsdale, Arizona, United States, 85251
United States, California
University of Southern California
Los Angeles, California, United States, 90033
Foothill Cardiology
Pasadena, California, United States, 91105
CMCA / Sequoia Hospital
Redwood City, California, United States, 94062
Sharp Memorial Hospital
San Diego, California, United States, 92123
Sharp Grossmont Hospital
San Diego, California, United States, 92123
Pacific Heart Institute
Santa Monica, California, United States, 90404
South Bay Electrophysiology
Torrance, California, United States, 90503
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30308
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Northwestern University
Chicago, Illinois, United States, 60611
Midwest Heart Foundation
Oakbrook Terrace, Illinois, United States, 60181
United States, Indiana
Parkview Research Center
Fort Wayne, Indiana, United States, 46805
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, North Carolina
Mid Carolina Cardiology Research
Charlotte, North Carolina, United States, 28204
Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29464
United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Sentara Heart Hospital
Norfolk, Virginia, United States, 23507
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
Heart Clinics Northwest
Spokane, Washington, United States, 99204
The Vancouver Clinic
Vancouver, Washington, United States, 98684
Netherlands
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, 8140
United Kingdom
Papworth Hospital NHS Trust
Papworth Everard, Cambridge, United Kingdom, CB3 8RE
Sponsors and Collaborators
Cameron Health, Inc.
Investigators
Study Director: Jon Hunt, Ph.D. Cameron Health, Inc.
  More Information

Additional Information:
No publications provided by Cameron Health, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cameron Health, Inc.
ClinicalTrials.gov Identifier: NCT01064076     History of Changes
Other Study ID Numbers: DN-03909
Study First Received: February 4, 2010
Last Updated: October 8, 2012
Health Authority: New Zealand: Medsafe
United States: Food and Drug Administration

Keywords provided by Cameron Health, Inc.:
ICD, defibrillator

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014