S-ICD® System IDE Clinical Study
This study is ongoing, but not recruiting participants.
Sponsor:
Cameron Health, Inc.
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
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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:
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01064076
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Hide Study LocationsLocations
| 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
| 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 May 16, 2013