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Taking people in PolandNo phase

Long-term reliability of Medtronic heart rhythm devices in heart patients

Tracks how long Medtronic heart devices keep working in people with arrhythmia.

Key facts

Who runs it
Medtronic
Where
Poznan, Warsaw, and Zabrze, PolandSee the 3 sitesAlso in 34 other countries, 333 sites
Trial code
Registry title
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
Status
Recruiting
People taking part
20,000 people, planned
Started
Jan 1983
Expected to end
Dec 2040
Type of study
Observational
Treatments tested
  • Device
Record updated
4 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people who are about to get, or just got, a Medtronic heart rhythm device (pacing, sensing or defibrillation). It follows how long the devices keep working.

Sex
All sexes can join.
Earlier treatment
People must be due to get, or have had within the last 30 days, at least one Medtronic market-released device for pacing, sensing or defibrillation. Or they took part in a qualifying study (IDE) of such a device with complete implant and follow-up data.

Main reasons for not taking part

  • People who cannot be reached for follow-up now or later
  • People with exclusion criteria required by local law (EMEA only)
  • People implanted at a non-participating center when implant data and current status cannot be confirmed within 30 days after implant
  • People with a Medtronic device whose set enrollment limit for that product has been exceeded

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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 who are, or will be inaccessible for follow-up
  • Subjects with exclusion criteria required by local law (EMEA only)
  • Subjects implanted with a Medtronic device whose predetermined enrollment limit for that specific product has been exceeded

Other criteria

  • Subjects who meet the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment

Where in Poland

Also in 34 other countries, 333 sites

  • PoznanHospital not named in the registryContact: Medtronic CRM Clinical TrialsNo longer taking part
  • WarsawHospital not named in the registryContact: Medtronic CRM Clinical TrialsTaking people
  • ZabrzeHospital not named in the registryContact: Medtronic CRM Clinical TrialsNo longer taking part

About the trial

What the trial wants to find out

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.

Treatments tested

  • Device

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Medtronic CRDM Product Performance Report
Plain-language title
Long-term reliability of Medtronic heart rhythm devices in heart patientsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
4 November 2026