Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Medtronic
The Medtronic CapSure Epi Lead Post-approval Study is being conducted as part of the requirements to satisfy the PMA conditions of approval for the Model 4968 lead. 100 subjects (adult and pediatric) with a 4968 lead will be followed for a minimum of five years to assess the long-term safety of the leads.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Provision of written informed consent and/or authorization for access to and use of health information by subjects or appropriate legal guardians as required by an institution's Investigational Review Board, Medical Ethics Board, or Research Ethics Board
Availability of implant, follow-up, and product-related event data
Implanted with a Model 4968 Capsure Epi Lead
You may not be if
Subjects receiving an implant of a Medtronic lead at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant
Subjects who are, or will be inaccessible for follow-up at a 4968 Post-approval study center
Subjects implanted with a Medtronic cardiac therapy device whose predetermined enrollment limit for that specific product has been exceeded
Clareo Health | Model 4968 CAPTURE EPI® STERIOD-ELUTING BIPOLAR EPICARDIAL PACING LEAD Post-approval Study
