Product Performance Platform

What we are studying

The purpose of this study is to collect information over time regarding how Medtronic systems are working in patients. The entire system includes the device (IPG, ICD, or CRT), the lead(s), and all associated parts. Medtronic has been collecting information about how their products work for over 25 years. This study is also being used to collect information needed by the Food and Drug Administration (FDA) in the United States to see how devices are working.

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Must be implanted or is intended to be implanted with at least one Medtronic market-released product
  • Must enroll within 30 days of implant or must have participated in the pre-market study phase for the product

What is involved

  • Participants may be in the study for as long as they have Medtronic products
  • Those with defibrillators or heart failure devices (ICD or CRT) will be seen every 6 months
  • Those with a pacemaker (IPG) will be seen every 12 months

Compensation

None

Contact Information

Study Coordinator
Deborah Wesley
Email
dwesley@wakehealth.edu
Phone
336-716-2924

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.