Longitudinal Surveillance Study of the 4-SITE Lead/Header System



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:3/8/2019
Start Date:April 2013
End Date:January 2020

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Post-approval studies of implanted leads provide an opportunity to observe and assess patient
outcomes and technology performance in a real-world setting. The goal of the study is to
evaluate, document and report on the appropriate clinical performance, long-term reliability
and the functional integrity of the Boston Scientific ENDOTAK RELIANCE® 4-SITE™ Lead and the
pulse generator 4-SITE Header.

The objective of the LSS of 4-SITE Study is to prospectively determine the chronic
complication-free rate of the 4-SITE Lead/Header System in order to verify its clinical
performance, long-term reliability and functional integrity. The LSS of 4-SITE Study is a
non-randomized, multi-center, global clinical investigation of subjects implanted with the
4-SITE Lead/Header System. The study is designed to collect product performance information,
any reportable adverse events and withdrawal data.

The primary purpose of this study is to evaluate, document and report on the appropriate
clinical performance, the long-term reliability and the functional integrity of the 4-SITE
Lead/Header System. This 4-SITE Lead/Header System consists of a 4-SITE ENDOTAK® RELIANCE
defibrillation lead connected to a 4-SITE Header (which is the only PG component under study)
of a single or dual chamber (VR and DR) implantable cardioverter defibrillator (ICD) or a
cardiac resynchronization therapy ICD (CRT-D) BSC pulse generator. Additionally,
system-related diagnostic information and implant data will be collected during the conduct
of this study.

Inclusion Criteria:

- medically indicated for ICD/CRT-D

- received/plan to receive study lead

- willing for long-term follow-up

Exclusion Criteria:

- unwilling to comply with protocol
We found this trial at
102
sites
12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Jacksonville, Florida 32207
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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Albany, Georgia 31701
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Anchorage, Alaska 99508
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Ann Arbor, Michigan 48197
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Baltimore, Maryland 21201
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Baltimore, Maryland 21237
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801 North 29th Street
Billings, Montana 59107
406-238-2500
Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
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Bradenton, Florida 34205
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Browns Mills, New Jersey 08015
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Burbank, California 91505
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Charleston, West Virginia 25304
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Chicago, Illinois 60637
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Cincinnati, Ohio 45267
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Clearwater, Florida 33756
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
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Columbia, South Carolina 29204
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Danbury, Connecticut 06810
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Des Moines, Iowa 50314
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Des Moines, Iowa 50266
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350 Engle St
Englewood, New Jersey 07631
(201) 894-3000
Englewood Hospital and Medical Center Englewood Hospital was incorporated in 1888 as a non-profit, non-sectarian...
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Escondido, California 92025
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Florence, South Carolina 29505
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Fort Lauderdale, Florida 33316
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Fort Wayne, Indiana 46805
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Fountain Valley, California
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Fountain Valley, California 92708
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Gainesville, Florida 32605
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Gainesville, Georgia
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Glendale, Arizona 85306
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Green Bay, Wisconsin 54305
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Greenwood, South Carolina 29646
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Houston, Texas 77024
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Jacksonville, Florida 32216
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Joliet, Illinois 60435
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Kansas City, Kansas 64114
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3535 Southern Blvd
Kettering, Ohio 45429
(937) 298-4331
Kettering Medical Center Our flagship hospital, Kettering Medical Center, stands proudly in Kettering, Ohio. From...
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Kissimmee, Florida 34741
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Lawrenceville, Georgia 30046
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Lexington, South Carolina 29072
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Lincoln, Nebraska 68526
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Little Rock, Arkansas 72205
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Los Angeles, California 90024
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Los Angeles, California 90033
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Los Angeles, California 93309
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Macon, Georgia 31201
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Madison, Wisconsin 53715
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Mesa, Arizona 85206
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Missoula, Montana 59802
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Morgantown, West Virginia 26505
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5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
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Nashville, Tennessee 37205
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New Orleans, Louisiana 70121
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Newton, Pennsylvania 18940
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600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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Palm Springs, California 92262
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Perth, Western Australia 6009
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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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Port Charlotte, Florida 33592
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Providence, Rhode Island 02904
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Rapid City, South Dakota 57701
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Riverside, California 92503
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Rochester, New York 14621
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Rogersville, Tennessee 37857
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Saginaw, Michigan 48602
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1406 6th Avenue North
Saint Cloud, Minnesota 56303
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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3635 Vista Avenue
Saint Louis, Missouri 63110
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Salem, Oregon 97309
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Salt Lake City, Utah 84132
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San Diego, California 92103
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San Jose, California 95008
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Santa Barbara, California 93105
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Seattle, Washington 98101
(888) 862-2737
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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101 E Wood St
Spartanburg, South Carolina 29303
(864) 560-6000
Spartanburg Regional Medical Center Spartanburg Regional is an integrated healthcare delivery system that provides care...
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Springfield, Missouri 65807
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Stockbridge, Georgia 30281
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Stony Brook, New York 24421
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Tallahassee, Florida 32308
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2142 N Cove Blvd
Toledo, Ohio 43606
(419) 291-4000
Toledo Hospital ProMedica’s Mission is to improve your health and well-being. And we at ProMedica...
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Torrance, California 90503
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105 Sixth St
Traverse City, Michigan 49684
(231) 935-5000
Munson Medical Center There’s no place quite like northern Michigan, and there is no other...
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Tupelo, Mississippi 38801
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Urbana, Illinois 61801
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929 N St Francis St
Wichita, Kansas 67214
(316) 268-5775
Via Christi Regional Medical Center Via Christi Health's rich history of serving the people of...
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Williamsville, New York 14221
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Yardley, Pennsylvania 19067
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