S-ICD® System IDE Clinical Study



Status:Archived
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:January 2010
End Date:October 2015

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S-ICD® System Clinical Investigation


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


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.


We found this trial at
30
sites
Redwood City, California 94062
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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201 East Huron Street
Chicago, Illinois 60611
(847) 491-3741
Northwestern University Northwestern is recognized both nationally and internationally for the quality of its educational...
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Chicago, IL
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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2160 South First Avenue
Proviso, Illinois 60153
(708) 216-0291
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110 Irving St NW # 3B28
Washington, Washington DC 20010
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Atlanta, Georgia 30322
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1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlotte, North Carolina 28204
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Cleveland, Ohio 44195
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Evanston, Illinois 60201
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Falls Church, Virginia 22042
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Fort Wayne, Indiana 46805
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Lenexa, Kansas 66124
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Lombard, Illinois 60148
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1983 Marengo St
Los Angeles, California 90033
(323) 226-2622
Los Angeles County-USC Medical Center The origins of LAC+USC Medical Center date back to 1878,...
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Mission Viejo, California 92691
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Norfolk, Virginia 23510
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Pasadena, California 91105
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2900 W Queen Ln
Philadelphia, Pennsylvania 19129
(215) 991-8100
Drexel University College of Medicine Drexel University College of Medicine represents the consolidation of two...
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7901 Frost Street
San Diego, California 92123
858-939-3400
Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
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Santa Monica, California 90404
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Scottsdale, Arizona 85251
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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Spokane, Washington 99204
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Vancouver, Washington 98664
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Winston-Salem, North Carolina 27103
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