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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMedtronic

About this trial

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.

Eligibility criteria

Qualifiers

None

Disqualifiers

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

Subjects who are, or will be inaccessible for follow-up

Subjects with exclusion criteria required by local law (EMEA only)

Trial design

Treatments tested in this trial

  • Device

Treatment groups

No treatment groups listed

Locations

320
Australia
Chermside Australia
Douglas Australia
Murdoch Australia
Southport Australia

Sponsors and collaborators

Medtronic

Lead sponsor