RecruitingArrhythmiaBradycardiaHeart Failure

Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products

Eligible age

All ages

Accepts

All genders

Locations

37 states

Healthy volunteers

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About this study

The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival probabilities.

Sponsor: Medtronic

You may qualify if…

✓ Subject 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:
✓ Subject is indicated for implant or within 30 days post-implant of at least one Medtronic market-released product used for a pacing, sensing or defibrillation application
✓ Subjects who participated in a qualifying study (IDE) of a Medtronic market-released product with complete implant and follow-up data and subject or appropriate legal guardian authorizes release of subject study data

You may not qualify if…

✕ Subjects who are, or will be inaccessible for follow-up
✕ Subjects with exclusion criteria required by local law (EMEA only)
✕ 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