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

Sponsor: Medtronic

NCT ID: NCT00271180

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Device (device)
How long the study runs
Study runs about 695 months (dates as stated)
About the drug or intervention
Device (device)
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at the long-term reliability and performance of Medtronic cardiac devices that are already on the market, in people with heart rhythm problems such as arrhythmia, bradycardia, heart failure and sinus tachycardia. The sponsor is Medtronic.

Who can take part

  • You (or your legal guardian) give written informed consent and permission for the study team to access and use your health information
  • You are due to have a Medtronic device implanted, or had one implanted within the last 30 days, for pacing, sensing or defibrillation
  • OR you took part in an earlier qualifying study (an IDE study) of a Medtronic device, with complete implant and follow-up data, and you agree to release that data

Who may not be able to

  • You cannot be reached for follow-up appointments
  • You are excluded under local law (in EMEA regions only)
  • You had a Medtronic device implanted at a hospital not taking part in the study, and your implant details and current status cannot be confirmed within 30 days of the implant
  • The study has already filled its set limit of participants for that particular Medtronic device

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team about visits, how long the study lasts and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
Not specified
Who
All
Number of participants
20,000
Started
1983-01
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for arrhythmia
  • • Clinical study - 20,000 participants
  • • 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

Who can take part?

  • • Adults
  • • Diagnosed with arrhythmia

Where?

  • • Birmingham
  • • Blackpool
  • • Bristol
  • • Leeds
  • • +9 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

More detail

All Medtronic market-released leads and all market-released IPG, ICD and CRT devices are eligible to be included in this study.

ArrhythmiaBradycardiaHeart FailureSinus Tachycardia

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: Not specified
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ by an institution's IRB/MEC/REB

What the study is looking for

  • ✓Subject or appropriate legal guardians provide written agreement to take part and/or authorization for access to and use...
  • ✓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...

Who cannot take part

  • ✗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...
  • ✗Subjects implanted with a Medtronic device whose predetermined enrollment limit for that specific product has been...
See the full criteria
Subjects who meet the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment. Inclusion Criteria: • 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 Exclusion Criteria: * 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

Where Is This Study? (13 UK sites)

Birmingham, United Kingdom

Recruiting

Blackpool, United Kingdom

TERMINATED

Bristol, United Kingdom

Recruiting

Leeds, United Kingdom

Recruiting

Leicester, United Kingdom

Recruiting

Liverpool, United Kingdom

Recruiting

London, United Kingdom

Recruiting

Manchester, United Kingdom

Recruiting

Middlesbrough, United Kingdom

Recruiting

Northampton, United Kingdom

TERMINATED

Nottingham, United Kingdom

TERMINATED

Sheffield, United Kingdom

Recruiting

Southampton, United Kingdom

Recruiting

How to Get in Touch

Medtronic CRM Clinical Trials

Sponsor contact

CONTACT

medtroniccrmtrials@medtronic.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-08