S-ICD® System Post Approval Study



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:4/6/2019
Start Date:March 12, 2013
End Date:October 2021

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Subcutaneous Implantable Cardioverter Defibrillator (S-ICD®) System Post Approval Study

The purpose of the S-ICD Post Approval Study is to document long term safety and
effectiveness outcomes associated with the implantation of the SQ-RX pulse generator and
Q-TRAK electrode in a commercial clinical setting.

The S-ICD Post Approval Study is a non-randomized registry that will retrospectively enroll
subjects who participated in the S-ICD Clinical Investigation (IDE G090013) and prospectively
enroll new candidates for the S-ICD System. The target enrollment sample size is 1,616
subjects at up to 150 investigational sites to achieve 1,025 subjects in the analysis cohort
at 60 months.

- The primary safety endpoint of the study is the Type I (caused by the S-ICD System)
Complication Free Rate at 60 months compared to a performance goal of 85%.

- The primary effectiveness endpoint is the Overall Shock Effectiveness in Converting
Spontaneous Discrete Episodes of ventricular tachycardia /ventricular fibrillation
(VT/VF) through 60 months compared to a performance goal of 94%.

- The secondary safety endpoint of the study is the Electrode-Related Complication Free
Rate at 60 months compared to a performance goal of 92.5%.

- The secondary effectiveness endpoint is First Shock Effectiveness in Converting Induced
(Acute) and Spontaneous Discrete Episodes of VT/VF through 60 months compared to a
performance goal of 84.0%.

Additional objectives include characterization of long term safety and effectiveness in
subjects of varied body habitus and in traditionally underrepresented populations.

Subjects must meet the following criteria to be eligible for inclusion in the study:

1. Eligible for implantation with an S-ICD System, OR previously implanted with an S-ICD
System in the S-ICD System Clinical Investigation (IDE G090013)

2. Willing and able to provide written informed consent or have informed consent provided
by a legal representative

Subjects who meet the following criteria must be excluded from the study:

1. Remaining life expectancy of less than 360 days

Enrolled subjects will be followed at the implant procedure, predischarge and annual(±60
days) follow-up visits. Subjects are followed according to the standard of care at their
participating investigational center.

Inclusion Criteria:

- Eligible for implantation with an S-ICD System, OR previously implanted with an S-ICD
System in the S-ICD System Clinical Investigation (IDE G090013)

AND

- Willing and able to provide written informed consent or have informed consent provided
by a legal representative

Exclusion Criteria:

- Remaining life expectancy of less than 360 days
We found this trial at
87
sites
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Edward Healey, MD
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Angel Leon
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Martin Burke
University of Chicago One of the world's premier academic and research institutions, the University of...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Mark Niebauer
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Albert Sun, MD
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Los Angeles, California 90033
213) 740-2311
Principal Investigator: Phillip Chang
University of Southern California The University of Southern California is one of the world’s leading...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Sharon Shen, MD
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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305 1st Avenue # Dazian 7
New York, New York 10003
(212) 420-2806
Beth Israel Med Ctr The physicians and staff of Mount Sinai Beth Israel's Heart Institute...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Fermin Garcia
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Akron, Ohio
Principal Investigator: Michael Pelini
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Albany, New York 12208
Principal Investigator: Mandeep Sidhu, MD
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Hamid Ghanbari, MD
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Augusta, Georgia 30901
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Augusta, Georgia 30912
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Baltimore, Maryland
Principal Investigator: Glenn Meininger, MD
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Bedford, Texas
Principal Investigator: Michael Delaughter, MD
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Boston, Massachusetts 02215
Principal Investigator: Melanie Maytin, MD
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Brooklyn, New York
Principal Investigator: Felix Yang, MD
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Burbank, California 91505
Principal Investigator: David Mok, MD
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1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
Principal Investigator: Andrea Russo
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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Cedar Rapids, Iowa
Principal Investigator: Mohit Chawla, MD
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Michael Gold
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlotte, North Carolina
Principal Investigator: Mark Kremers
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Charlottesville, Virginia 22908
Principal Investigator: Pamela Mason, MD
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Bradley Knight
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1006 South Michigan Avenue
Chicago, Illinois 60605
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Cincinnati, Ohio 45220
Principal Investigator: Marshall Winner, MD
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Cleveland, Ohio 44106
Principal Investigator: Judith Mackall, MD
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Colorado Springs, Colorado
Principal Investigator: Brad Mikaelian, MD
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Columbia, South Carolina 29204
Principal Investigator: Venkateshwar Gottipaty, MD
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Columbus, Ohio
Principal Investigator: James Kleman, MD
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Raul Weiss
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
(763) 236-6000
Principal Investigator: Stephen Remole, MD
Mercy Hospital Mercy Hospital, located in Coon Rapids, Minnesota, is a 271-bed non-profit hospital that...
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Dallas, Texas 75231
Principal Investigator: Mustafa Dohadwala, MD
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: Claudio Schuger
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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East Palo Alto, California
Principal Investigator: R. Hardwin Mead
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El Cajon, California
Principal Investigator: Peter Belott
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Falls Church, Virginia 22042
Principal Investigator: Ted Friehling
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1200 North Federal Highway
Fort Lauderdale, Florida 33432
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Fort Wayne, Indiana 46805
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Fountain Valley, California
Principal Investigator: Thuy Le, MD
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Haddon Heights, New Jersey 08035
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2900 1st Avenue
Huntington, West Virginia 25702
Principal Investigator: Esam Baryun, MD
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Huntsville, Alabama 35801
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Kansas City, Missouri
Principal Investigator: Alan Wimmer, MD
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La Jolla, California 92037
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Lawrenceville, Georgia 30045
Principal Investigator: Niraj Sharma
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Little Rock, Arkansas 72205
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Lombard, Illinois
Principal Investigator: Moeen Saleem
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Louisville, Kentucky
Principal Investigator: Robert Schwartz, MD
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Manchester, New Hampshire 03102
Principal Investigator: Jamie Kim, MD
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Mesa, Arizona 85206
Principal Investigator: Andrew Kaplan, MD
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800 E 28th St
Minneapolis, Minnesota 55407
(612) 863-4000
Principal Investigator: Charles Gornick
Abbott Northwestern Hospital Our hospital has a long and proud history as a health care...
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Muncie, Indiana
Principal Investigator: Bruce Graham, MD
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Neptune, New Jersey 07753
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New York, New York
Principal Investigator: Marc Miller, MD
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Norfolk, Virginia 23507
Principal Investigator: John Herre
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Omaha, Nebraska
Principal Investigator: Hassam Abussia, MD
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Pasadena, California
Principal Investigator: Mayer Rashtian
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1801 N Broad St
Philadelphia, Pennsylvania 19122
(215) 204-7000
Principal Investigator: Joshua Cooper, MD
Temple University Temple University is many things to many people. A place to pursue life's...
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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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Phoenix, Arizona
Principal Investigator: Asish Sadhu, MD
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Portland, Oregon 97227
Principal Investigator: Charles Henrikson, MD
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Richmond, Virginia
Principal Investigator: Karoly Kaszala, MD
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Richmond, Virginia 23225
Principal Investigator: Charles Joyner, MD
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711 West Main Street
Richmond, Virginia 23220
Principal Investigator: Gauthem Kalahasty, MD
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223 N Van Dien Ave
Ridgewood, New Jersey 07450
(201) 447-8000
The Valley Hospital The Valley Hospital is a fully accredited, acute care, not-for-profit hospital serving...
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Saint Louis, Missouri 63110
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Salt Lake City, Utah
Principal Investigator: Roger Freedman, MD
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7901 Frost Street
San Diego, California 92123
858-939-3400
Principal Investigator: M. Charles Athill
Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
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Santa Monica, California
Principal Investigator: Shephal Doshi
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Savannah, Georgia
Principal Investigator: Michael Chisner, MD
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Scottsdale, Arizona
Principal Investigator: Thomas Mattioni
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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
Principal Investigator: Etri Byazrova
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Springfield, Missouri
Principal Investigator: Steven Rowe, MD
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100 Nicolls Road
Stony Brook, New York 11794
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Tampa, Florida 33612
Principal Investigator: Raymond Cutro, MD
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Tampa, Florida
Principal Investigator: Kenneth Yamamura, MD
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The Woodlands, Texas 77384
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2142 N Cove Blvd
Toledo, Ohio 43606
(419) 291-4000
Principal Investigator: Johan Aasbo
Toledo Hospital ProMedica’s Mission is to improve your health and well-being. And we at ProMedica...
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Tucson, Arizona 85712
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Vancouver, Washington 98664
Principal Investigator: Robert Swenson
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110 Irving St NW
Washington, District of Columbia 20010
(202) 877-7000
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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Willoughby, Ohio 44094
Principal Investigator: Robert Goldstein, MD
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Winston-Salem, North Carolina 27103
Principal Investigator: Michael Drucker
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