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

Completed

• Conditions: Secondary Prevention of Sudden Cardiac Arrest; Primary 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.

Study Timeline

• Study First Submitted: 2012-05-03
• Study First Submitted QC: 2012-05-09
• Study First Posted: 2012-05-11
• Study Start: 2013-04-04
• Primary Completion: 2020-02-18
• Study Completion: 2020-02-18
• Status Verified: 2021-02
• Results First Submitted: 2021-02-03
• Results First Submitted QC: 2021-02-03
• Results First Posted: 2021-02-21
• Last Update Submitted: 2021-02-25
• Last Update Posted: 2021-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1820

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

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.

Trial Locations

Locations (111)

Providence Alaska Medical Center; 🇺🇸 Anchorage, Alaska, United States

Cardiovascular Consultants, LTD; 🇺🇸 Glendale, Arizona, United States

Cardiovascular Associates of Mesa; 🇺🇸 Mesa, Arizona, United States

Phoenix Cardiovascular Research Group; 🇺🇸 Phoenix, Arizona, United States

Heart Clinic Arkansas; 🇺🇸 Little Rock, Arkansas, United States

Providence St. Joseph Medical Center; 🇺🇸 Burbank, California, United States

Palomar Medical Center; 🇺🇸 Escondido, California, United States

California Heart Associates; 🇺🇸 Fountain Valley, California, United States

Luc Sinh Nguyen, MD, FACC, Inc.; 🇺🇸 Fountain Valley, California, United States

Providence Holy Cross Medical Center; 🇺🇸 Los Angeles, California, United States

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