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
This trial does not accept healthy volunteersQualifiers
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 population
Subjects implanted with Medtronic qualifying cardiac rhythm product.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Device
Device
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Lead related complications for each lead model.
All follow-up visits will be utilized in the analyses. This is an observational study that does not have a statistically powered primary hypothesis. Therefore, a specific study sample size is not applicable.
Time frame
Ongoing: Implant to the cardiac lead is terminated from the study if the patient exit, patient death, or out-of-service (e.g. deactivated/inactive). Source ClinicalTrials.gov