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

NCT01596595 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1820

Last updated 2021-03-19

Study results available
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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.

Conditions

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

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Stephen Kutalek, MD · Drexel University, USA

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-04
Primary Completion
2020-02-18
Completion
2020-02-18

Countries

  • United States
  • Australia
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01596595 on ClinicalTrials.gov