Study Results
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View full resultsBasic Information
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COMPLETED
NA
330 participants
INTERVENTIONAL
2010-01-31
2013-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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S-ICD System
This is a single arm study
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).
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
• 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
* 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.
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Husby, M.S., MPH
Role: STUDY_DIRECTOR
Cameron Health, Inc. a Subsidiary of Boston Scientific
Locations
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Arizona Arrhythmia Consultants
Scottsdale, Arizona, United States
University of Southern California
Los Angeles, California, United States
Foothill Cardiology
Pasadena, California, United States
CMCA / Sequoia Hospital
Redwood City, California, United States
Sharp Grossmont Hospital
San Diego, California, United States
Sharp Memorial Hospital
San Diego, California, United States
Pacific Heart Institute
Santa Monica, California, United States
South Bay Electrophysiology
Torrance, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Midwest Heart Foundation
Oakbrook Terrace, Illinois, United States
Parkview Research Center
Fort Wayne, Indiana, United States
Cooper University Hospital
Camden, New Jersey, United States
Mount Sinai School of Medicine
New York, New York, United States
Mid Carolina Cardiology Research
Charlotte, North Carolina, United States
Forsyth Medical Center
Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Sentara Heart Hospital
Norfolk, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
Heart Clinics Northwest
Spokane, Washington, United States
The Vancouver Clinic
Vancouver, Washington, United States
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
Auckland City Hospital
Auckland, , New Zealand
Christchurch Hospital
Christchurch, , New Zealand
Papworth Hospital NHS Trust
Papworth Everard, Cambridge, United Kingdom
Countries
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References
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Amin AK, Gold MR, Burke MC, Knight BP, Rajjoub MR, Duffy E, Husby M, Stahl WK, Weiss R. Factors Associated With High-Voltage Impedance and Subcutaneous Implantable Defibrillator Ventricular Fibrillation Conversion Success. Circ Arrhythm Electrophysiol. 2019 Apr;12(4):e006665. doi: 10.1161/CIRCEP.118.006665.
Burke MC, Gold MR, Knight BP, Barr CS, Theuns DAMJ, Boersma LVA, Knops RE, Weiss R, Leon AR, Herre JM, Husby M, Stein KM, Lambiase PD. Safety and Efficacy of the Totally Subcutaneous Implantable Defibrillator: 2-Year Results From a Pooled Analysis of the IDE Study and EFFORTLESS Registry. J Am Coll Cardiol. 2015 Apr 28;65(16):1605-1615. doi: 10.1016/j.jacc.2015.02.047.
Weiss R, Knight BP, Gold MR, Leon AR, Herre JM, Hood M, Rashtian M, Kremers M, Crozier I, Lee KL, Smith W, Burke MC. Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator. Circulation. 2013 Aug 27;128(9):944-53. doi: 10.1161/CIRCULATIONAHA.113.003042.
Related Links
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Boston Scientific Website
Other Identifiers
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DN-03909
Identifier Type: -
Identifier Source: org_study_id
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