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.
Brief Title
Longitudinal Surveillance Study of the 4-SITE Lead/Header System
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Primary Prevention of Sudden Cardiac Arrest
Secondary Prevention of Sudden Cardiac Arrest
Eligibility Criteria
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
* 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
Inclusion Criteria
Inclusion Criteria:
* medically indicated for ICD/CRT-D
* received/plan to receive study lead
* willing for long-term follow-up
* medically indicated for ICD/CRT-D
* received/plan to receive study lead
* willing for long-term follow-up
Gender
All
Gender Based
false
Keywords
ICD
CRT-D
Defibrillation lead
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
NCT Id
NCT01596595
Org Class
Industry
Org Full Name
Boston Scientific Corporation
Org Study Id
LSS of 4-SITE
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Longitudinal Surveillance Study of the 4-SITE Lead/Header System
Primary Outcomes
Outcome Description
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.
Outcome Measure
Percentage of Participants Not Experiencing a System or Procedure Related Complication Through 5-years
Outcome Time Frame
5 years
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
From Physicians patient population
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jay Gross
Investigator Email
jagross@montefiore.org
Investigator Phone