Longitudinal Surveillance Study of the 4-SITE Lead/Header System (LSS of 4-SITE)
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.
Primary Prevention of Sudden Cardiac Arrest
Secondary Prevention of Sudden Cardiac Arrest
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Longitudinal Surveillance Study of the 4-SITE Lead/Header System|
- 5 Year Chronic Lead Complication Free Rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||August 2021|
|Estimated Primary Completion Date:||March 2021 (Final data collection date for primary outcome measure)|
Medically Indicated for ICD or CRT-D
Medically Indicated for ICD or CRT-D implantation per guidelines
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.
|Contact: Anne Swearingen, MSN||800-227-3422 ext firstname.lastname@example.org|
|United States, Connecticut|
|Danbury, Connecticut, United States|
|Principal Investigator:||Stephen Kutalek, MD||Drexel University, USA|