Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Medtronic
The rate of device malfunctions will be determined and a comparison to historical controls will be done.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects or appropriate legal guardians provide written informed consent and/or authorization for access to and use of health information, as required by an institution's IRB/MEC/REB.
AND one of the following must also apply:
Subjects indicated for implant or within six months post-implant of a Medtronic market-released lead connected to a Medtronic Adapta®, Sensia™, or Versa™ IPG. The Medtronic lead must be used for pacing, sensing or defibrillation application.
Subjects who participated in a qualifying study (IDE) of a Medtronic cardiac therapy product and: 1) have a Medtronic Adapta®, Sensia™, or Versa™ IPG 2)product is market-released 3) complete implant and follow-up data, including product-related adverse events are available and 4) subject of appropriate legal guardian authorizes release of subject study data to SLS
Subjects implanted with a Medtronic Adapta®, Sensia™, or Versa™ IPG and Medtronic CapSure Epi Leads (model 4965 and 4968) at a minimum of three pre-selected sites to retrospectively collect data for post approval requirements.
You may not be if
Subjects who are, or will be inaccessible for follow-up at a SLS center
Subjects receiving an implant of a Medtronic device at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant
Subjects implanted with a Medtronic device whose predetermined enrollment limit for that specific product has been exceeded
Clareo Health | MEDTRONIC ADAPTA, VERSA AND SENSIA nEw3 POST APPROVAL STUDY
