The Longitudinal Surveillance Study of the 4-SITE lead/Header System

Trial ID:
IRB-14-6349
Manish Wadhwa
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 RELIANCEĀ® 4-SITEā„¢ Lead and the pulse generator 4-SITE Header.

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

Contact Info:

  • Anne Swearingen, MSN
  • anne.swearingen@bsci.com
  • 800-227-3422