Clinical Trial:

Optisure

Full Name

Optisure Lead Post Approval Study (2_PRO00002407)

Description

Patients who choose to take part have been or will be implanted with a St. Jude Medical (SJM) Optisure lead within the past 30 days. This post-approval research study will allow St. Jude Medical (sponsor of the study) to continue to monitor the information about the leads for up to five years from the date of the implant. Participants who choose to take part in this study will be required to return for follow-up visits. The function of the device will be checked at each of those visits. The visits will occur every 6 months from the date of hospital discharge, for 5 years. The follow-up visits will occur in the clinic, and the device will be tested using a programmer (computer). Participants should not feel any discomfort during this procedure. It should take no longer than 15 minutes to gather information on the device. The study doctor or nurse will ask questions regarding the participant’s health. Participants will be required to carry an identification card indicating they are participating in a research study.

Eligibility

Inclusion Criteria
Inclusion Criteria-including but may not be limited to:
  • Must be 18 years of age or older
  • Must have been implanted with a St. Jude Medical Optisure lead in the last 30 days or are scheduled for an Optisure lead implant
  • Must not have a life expectancy of less than5 years due to any condition