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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Primary Prevention of Sudden Cardiac Arrest, Secondary Prevention of Sudden Cardiac Arrest

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Medically Indicated for ICD or CRT-D<br>Medically Indicated for ICD or CRT-D implantation per guidelines | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Not Experiencing a System or Procedure Related Complication Through 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. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICD, CRT-D, Defibrillation lead