S-ICD® System IDE Clinical Study
S-ICD® System Clinical Investigation
1 other identifier
interventional
330
4 countries
33
Brief Summary
This clinical study is designed to evaluate the safety and effectiveness of the subcutaneous implantable defibrillator (S-ICD) System.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2010
Typical duration for not_applicable
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 4, 2010
CompletedFirst Posted
Study publicly available on registry
February 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedResults Posted
Study results publicly available
March 27, 2017
CompletedMarch 27, 2017
July 1, 2015
1.7 years
February 4, 2010
November 19, 2014
February 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Free of Type I Complications at 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
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
Study Arms (1)
S-ICD System
EXPERIMENTALThis is a single arm study
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Arizona Arrhythmia Consultants
Scottsdale, Arizona, 85251, United States
University of Southern California
Los Angeles, California, 90033, United States
Foothill Cardiology
Pasadena, California, 91105, United States
CMCA / Sequoia Hospital
Redwood City, California, 94062, United States
Sharp Grossmont Hospital
San Diego, California, 92123, United States
Sharp Memorial Hospital
San Diego, California, 92123, United States
Pacific Heart Institute
Santa Monica, California, 90404, United States
South Bay Electrophysiology
Torrance, California, 90503, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Emory University School of Medicine
Atlanta, Georgia, 30308, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Midwest Heart Foundation
Oakbrook Terrace, Illinois, 60181, United States
Parkview Research Center
Fort Wayne, Indiana, 46805, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Mid Carolina Cardiology Research
Charlotte, North Carolina, 28204, United States
Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Medical University of South Carolina
Charleston, South Carolina, 29464, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Sentara Heart Hospital
Norfolk, Virginia, 23507, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Heart Clinics Northwest
Spokane, Washington, 99204, United States
The Vancouver Clinic
Vancouver, Washington, 98684, United States
St. Antonius Ziekenhuis
Nieuwegein, 3435 CM, Netherlands
Erasmus Medical Center
Rotterdam, 3015 GD, Netherlands
Auckland City Hospital
Auckland, 1001, New Zealand
Christchurch Hospital
Christchurch, 8140, New Zealand
Papworth Hospital NHS Trust
Papworth Everard, Cambridge, CB3 8RE, United Kingdom
Related Publications (3)
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.
PMID: 30917689DERIVEDBurke 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.
PMID: 25908064DERIVEDWeiss 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.
PMID: 23979626DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The major limitation of this study is the lack of a control group and the relatively short follow-up time.
Results Point of Contact
- Title
- Michael Husby, Clinical Studies Manager
- Organization
- Cameron Health, Inc. a subsidiary of Boston Scientific
Study Officials
- STUDY DIRECTOR
Michael Husby, M.S., MPH
Cameron Health, Inc. a Subsidiary of Boston Scientific
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2010
First Posted
February 8, 2010
Study Start
January 1, 2010
Primary Completion
October 1, 2011
Study Completion
January 1, 2013
Last Updated
March 27, 2017
Results First Posted
March 27, 2017
Record last verified: 2015-07