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Completed

NCT Number: NCT01596595

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

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.

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Key information

Conditions

Primary Prevention of Sudden Cardiac Arrest Secondary Prevention of Sudden Cardiac Arrest

Sex eligibility

All sexes

Study type

Observational

Primary location

Mount Hospital, Perth, Western Australia, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Percentage of Participants Not Experiencing a System or Procedure Related Complication Through 5-years

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Acronym: LSS of 4-SITE

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
May 11, 2012
Registry last updated
Mar 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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