N/A
Completed N=1,779
Longitudinal Surveillance Study of the 4-SITE Lead/Header System
Primary Prevention of Sudden Cardiac Arrest · Secondary Prevention of Sudden Cardiac Arrest
Source: ClinicalTrials.gov NCT01596595 ↗
Enrolled (actual)
1,779
Serious AEs
55.9%
Results posted
Feb 2021
Primary outcomePrimary: Percentage of Participants Not Experiencing a System or Procedure Related Complication Through 5-years — 98.9 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Not Experiencing a System or Procedure Related Complication Through 5-years |
98.9 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01596595). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.