Overview

This trial is active, not recruiting.

Conditions primary prevention of sudden cardiac arrest, secondary prevention of sudden cardiac arrest
Sponsor Boston Scientific Corporation
Start date April 2013
End date January 2020
Trial size 1820 participants
Trial identifier NCT01596595, LSS of 4-SITE

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Medically Indicated for ICD or CRT-D implantation per guidelines

Primary Outcomes

Measure
5 Year Chronic Lead Complication Free Rate
time frame: 5 years

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Longitudinal Surveillance Study of the 4-SITE Lead/Header System
Principal investigator Stephen Kutalek, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.