Longitudinal Surveillance Study of the 4-SITE Lead/Header System
NCT ID: NCT01596595
Last Updated: 2021-03-19
Study Results
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View full resultsBasic Information
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COMPLETED
1820 participants
OBSERVATIONAL
2013-04-04
2020-02-18
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Medically Indicated for ICD or CRT-D
Medically Indicated for ICD or CRT-D implantation per guidelines
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* received/plan to receive study lead
* willing for long-term follow-up
Exclusion Criteria
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Stephen Kutalek, MD
Role: PRINCIPAL_INVESTIGATOR
Drexel University, USA
Locations
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Providence Alaska Medical Center
Anchorage, Alaska, United States
Cardiovascular Consultants, LTD
Glendale, Arizona, United States
Cardiovascular Associates of Mesa
Mesa, Arizona, United States
Phoenix Cardiovascular Research Group
Phoenix, Arizona, United States
Heart Clinic Arkansas
Little Rock, Arkansas, United States
Providence St. Joseph Medical Center
Burbank, California, United States
Palomar Medical Center
Escondido, California, United States
California Heart Associates
Fountain Valley, California, United States
Luc Sinh Nguyen, MD, FACC, Inc.
Fountain Valley, California, United States
Providence Holy Cross Medical Center
Los Angeles, California, United States
Cardiac Device Rhythm Specialists
Los Angeles, California, United States
Comprehensive Cardiovascular Medical Group
Los Angeles, California, United States
Desert Regional Medical Center
Palm Springs, California, United States
Truong D. Duong, MD. A Medical Corporation
Riverside, California, United States
San Diego Arrhythmia Associates
San Diego, California, United States
Good Samaritan Hospital - San Jose
San Jose, California, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, United States
Little Company of Mary Hospital
Torrance, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
South Denver Cardiology Associates, PC
Denver, Colorado, United States
Danbury Hospital
Danbury, Connecticut, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Bradenton Cardiology
Bradenton, Florida, United States
Clearwater Cardiovascular Consultants
Clearwater, Florida, United States
Broward General Medical Center
Fort Lauderdale, Florida, United States
North Florida Regional Medical Center
Gainesville, Florida, United States
First Coast Cardiovascular
Jacksonville, Florida, United States
Baptist Medical Center
Jacksonville, Florida, United States
Osceola Regional Medical Center
Kissimmee, Florida, United States
Cardiovascular Research Center of South Florida
Miami, Florida, United States
Charlotte Heart & Vascular
Port Charlotte, Florida, United States
Brevard Cardiovascular Research Associates, Inc.
Rockledge, Florida, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Phoebe Putney Memorial Hospital
Albany, Georgia, United States
Northeast Georgia Heart Center
Gainesville, Georgia, United States
Gwinnett Hospital System Inc.
Lawrenceville, Georgia, United States
Georgia Arrhythmia Consultants
Macon, Georgia, United States
Atlanta Heart Associates
Stockbridge, Georgia, United States
University of Chicago Hospital
Chicago, Illinois, United States
Illinois Heart and Vascular at Adventist Hinsdale Hospital
Hinsdale, Illinois, United States
Heartland Cardiovascular Center
Joliet, Illinois, United States
Carle Foundation Hospital
Urbana, Illinois, United States
Bloomington Hospital
Bloomington, Indiana, United States
Parkview Memorial Hospital
Fort Wayne, Indiana, United States
Mercy Hospital Medical Center
Des Moines, Iowa, United States
The Iowa Clinic, PC
Des Moines, Iowa, United States
Kansas City Heart Foundation
Kansas City, Kansas, United States
Via-Christi Regional Medical Center
Wichita, Kansas, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
University of Maryland Medical System
Baltimore, Maryland, United States
MedStar Health Research Institute
Baltimore, Maryland, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Covenant Medical Center
Saginaw, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Centracare Heart and Vascular Center
Saint Cloud, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
North Mississippi Medical Center
Tupelo, Mississippi, United States
Cox Health
Springfield, Missouri, United States
St. Louis University Hospital
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Billings Clinic
Billings, Montana, United States
St. Patrick Hospital
Missoula, Montana, United States
Nebraska Heart Institute
Lincoln, Nebraska, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, United States
Cardiovascular Associates of the Delaware Valley
Sewell, New Jersey, United States
North Shore University Hospital
Manhasset, New York, United States
Rochester General Hospital
Rochester, New York, United States
SUNY-Stony Brook School of Medicine
Stony Brook, New York, United States
Cardiology Group of West New York
Williamsville, New York, United States
Universtity of Cincinnati
Cincinnati, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
The Toledo Hospital
Toledo, Ohio, United States
Genesis Healthcare System
Zanesville, Ohio, United States
Salem Hospital
Salem, Oregon, United States
The Arrhythmia Institute
Newton, Pennsylvania, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
Cardiology Consultants of Philadelphia
Yardley, Pennsylvania, United States
Southcoast Physicians Group
Providence, Rhode Island, United States
Sisters of Charity Providence Hospital
Columbia, South Carolina, United States
PeeDee Cardiology Associates PA
Florence, South Carolina, United States
Piedmont Medical Center
Greenwood, South Carolina, United States
Lexington Medical Center
Lexington, South Carolina, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Rapid City Regional Hospit
Rapid City, South Dakota, United States
Saint Thomas Health
Nashville, Tennessee, United States
Wellmont Holston Valley Medical Center
Rogersville, Tennessee, United States
SouthEast Texas Clinical Research Center
Beaumont, Texas, United States
Houston Arrhythmia Associates
Houston, Texas, United States
Arrhythmia Associates of South Texas
San Antonio, Texas, United States
Trinity Mother Frances Health System
Tyler, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Utah Hospital and Clinics
Salt Lake City, Utah, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Virginia Commonwealth University Health System
Richmond, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Charleston Area Medical Center
Charleston, West Virginia, United States
Monongalia General Hospital
Morgantown, West Virginia, United States
Bellin Health
Green Bay, Wisconsin, United States
Meriter Hospital, Inc.
Madison, Wisconsin, United States
Cheyenne Regional Medical Center
Cheyenne, Wyoming, United States
Mount Hospital
Perth, Western Australia, Australia
Foothills Medical Centre
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Royal Columbian Hospital
New Westminster, British Columbia, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
Fleurimont Hospital
Sherbrooke, Quebec, Canada
Institut universitaire de Cardiologie et de Pneumologie de Quebec
Ste Foy, Quebec, Canada
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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LSS of 4-SITE
Identifier Type: -
Identifier Source: org_study_id
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