An observational study in Arrhythmia, Bradycardia and Heart Failure, sponsored by Medtronic. Recruiting at 338 sites in 35 countries. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Medtronic · Observational
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.
All Medtronic market-released leads and all market-released IPG, ICD and CRT devices are eligible to be included in this study.
317 studies on the registry are indexed under Bradycardia; 71 are open to participants now.
This study's planned enrollment of 20,000 is above the median of 257 across 127 observational studies indexed under Bradycardia.
Browse Bradycardia studies →Medtronic is the lead sponsor of 42 studies on the registry; 5 are open to participants now.
Compared within Bradycardia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Arrhythmias, Cardiac. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Subjects implanted with Medtronic qualifying cardiac rhythm product.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects who meet the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.
Inclusion Criteria:
AND one of the following must also apply:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
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Showing the first 100 of 338 sites across 35 countries. Choose a country and city above to see the rest.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.