Longitudinal Surveillance Study of the 4-SITE Lead/Header System
- Conditions
- Secondary Prevention of Sudden Cardiac ArrestPrimary Prevention of Sudden Cardiac Arrest
- Registration Number
- NCT01596595
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1820
- medically indicated for ICD/CRT-D
- received/plan to receive study lead
- willing for long-term follow-up
- unwilling to comply with protocol
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants Not Experiencing a System or Procedure Related Complication Through 5-years 5 years The 4-SITE Lead/Header System will be evaluated based on the "chronic 4-SITE Lead/Header System-related complication-free rate" for the five (5) year follow-up period after the index implantation. The primary endpoint analysis will include confirmed chronic 4-SITE Lead/Header System-related complications that result in study subject permanent loss of therapy, invasive intervention, injury or death.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (111)
Clearwater Cardiovascular Consultants
🇺🇸Clearwater, Florida, United States
Little Company of Mary Hospital
🇺🇸Torrance, California, United States
First Coast Cardiovascular
🇺🇸Jacksonville, Florida, United States
Cardiovascular Associates of Mesa
🇺🇸Mesa, Arizona, United States
Truong D. Duong, MD. A Medical Corporation
🇺🇸Riverside, California, United States
Baptist Medical Center
🇺🇸Jacksonville, Florida, United States
Desert Regional Medical Center
🇺🇸Palm Springs, California, United States
Phoebe Putney Memorial Hospital
🇺🇸Albany, Georgia, United States
Palomar Medical Center
🇺🇸Escondido, California, United States
Good Samaritan Hospital - San Jose
🇺🇸San Jose, California, United States
Luc Sinh Nguyen, MD, FACC, Inc.
🇺🇸Fountain Valley, California, United States
Santa Barbara Cottage Hospital
🇺🇸Santa Barbara, California, United States
Cardiac Device Rhythm Specialists
🇺🇸Los Angeles, California, United States
Providence Holy Cross Medical Center
🇺🇸Los Angeles, California, United States
Comprehensive Cardiovascular Medical Group
🇺🇸Los Angeles, California, United States
Bradenton Cardiology
🇺🇸Bradenton, Florida, United States
Georgia Arrhythmia Consultants
🇺🇸Macon, Georgia, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Cardiovascular Research Center of South Florida
🇺🇸Miami, Florida, United States
San Diego Arrhythmia Associates
🇺🇸San Diego, California, United States
Arrhythmia Associates of South Texas
🇺🇸San Antonio, Texas, United States
Broward General Medical Center
🇺🇸Fort Lauderdale, Florida, United States
Brevard Cardiovascular Research Associates, Inc.
🇺🇸Rockledge, Florida, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Osceola Regional Medical Center
🇺🇸Kissimmee, Florida, United States
Cardiovascular Consultants, LTD
🇺🇸Glendale, Arizona, United States
Providence St. Joseph Medical Center
🇺🇸Burbank, California, United States
Providence Alaska Medical Center
🇺🇸Anchorage, Alaska, United States
Heart Clinic Arkansas
🇺🇸Little Rock, Arkansas, United States
California Heart Associates
🇺🇸Fountain Valley, California, United States
Danbury Hospital
🇺🇸Danbury, Connecticut, United States
Charlotte Heart & Vascular
🇺🇸Port Charlotte, Florida, United States
Tallahassee Memorial Hospital
🇺🇸Tallahassee, Florida, United States
Northeast Georgia Heart Center
🇺🇸Gainesville, Georgia, United States
Gwinnett Hospital System Inc.
🇺🇸Lawrenceville, Georgia, United States
Atlanta Heart Associates
🇺🇸Stockbridge, Georgia, United States
Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
University of Chicago Hospital
🇺🇸Chicago, Illinois, United States
Illinois Heart and Vascular at Adventist Hinsdale Hospital
🇺🇸Hinsdale, Illinois, United States
Bloomington Hospital
🇺🇸Bloomington, Indiana, United States
Parkview Memorial Hospital
🇺🇸Fort Wayne, Indiana, United States
Heartland Cardiovascular Center
🇺🇸Joliet, Illinois, United States
The Iowa Clinic, PC
🇺🇸Des Moines, Iowa, United States
Mercy Hospital Medical Center
🇺🇸Des Moines, Iowa, United States
Via-Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Kansas City Heart Foundation
🇺🇸Kansas City, Kansas, United States
MedStar Health Research Institute
🇺🇸Baltimore, Maryland, United States
University of Maryland Medical System
🇺🇸Baltimore, Maryland, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, 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
North Mississippi Medical Center
🇺🇸Tupelo, Mississippi, United States
St. Louis University Hospital
🇺🇸Saint Louis, Missouri, United States
Billings Clinic
🇺🇸Billings, Montana, United States
Cox Health
🇺🇸Springfield, Missouri, United States
Englewood Hospital and Medical Center
🇺🇸Englewood, New Jersey, United States
Deborah Heart and Lung Center
🇺🇸Browns Mills, New Jersey, United States
Nebraska Heart Institute
🇺🇸Lincoln, Nebraska, United States
Cardiovascular Associates of the Delaware Valley
🇺🇸Sewell, New Jersey, United States
SUNY-Stony Brook School of Medicine
🇺🇸Stony Brook, New York, United States
Universtity of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Cardiology Group of West New York
🇺🇸Williamsville, New York, United States
Kettering Medical Center
🇺🇸Kettering, Ohio, United States
Genesis Healthcare System
🇺🇸Zanesville, Ohio, United States
The Toledo Hospital
🇺🇸Toledo, 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
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
Intermountain Medical Center
🇺🇸Murray, Utah, United States
Meriter Hospital, Inc.
🇺🇸Madison, Wisconsin, United States
Bellin Health
🇺🇸Green Bay, Wisconsin, United States
Charleston Area Medical Center
🇺🇸Charleston, West Virginia, United States
Monongalia General Hospital
🇺🇸Morgantown, West Virginia, 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
Fleurimont Hospital
🇨🇦Sherbrooke, Quebec, Canada
Institut universitaire de Cardiologie et de Pneumologie de Quebec
🇨🇦Ste Foy, Quebec, Canada
North Shore University Hospital
🇺🇸Manhasset, New York, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
Rochester General Hospital
🇺🇸Rochester, New York, United States
St. Patrick Hospital
🇺🇸Missoula, Montana, United States
Royal Columbian Hospital
🇨🇦New Westminster, British Columbia, Canada
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada
Phoenix Cardiovascular Research Group
🇺🇸Phoenix, Arizona, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
South Denver Cardiology Associates, PC
🇺🇸Denver, Colorado, United States
Saint Thomas Health
🇺🇸Nashville, Tennessee, United States
University of Utah Hospital and Clinics
🇺🇸Salt Lake City, Utah, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Trinity Mother Frances Health System
🇺🇸Tyler, Texas, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
St. Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
Virginia Commonwealth University Health System
🇺🇸Richmond, Virginia, United States
North Florida Regional Medical Center
🇺🇸Gainesville, Florida, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States