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Product Surveillance Registry

Sponsor: Medtronic

NCT ID: NCT01524276

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
Not specified by the sponsor
How long the study runs
Study runs about 336 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor

In plain English

This is a product surveillance registry run by Medtronic. It collects information from patients who have, or are due to receive, an eligible Medtronic product, covering a wide range of conditions such as heart rhythm problems, neurological disorders and coronary artery disease. The aim is to gather ongoing information about how these products perform.

Who can take part

  • You (or your legal representative) give written permission or consent, following the rules of your hospital and country
  • You have, or are due to receive or be treated with, an eligible Medtronic product
  • You are within the enrolment window for starting your treatment, or you meet the rules for joining after treatment has started

Who may not be able to

  • You cannot be reached for follow-up checks, now or in the future
  • Local law says you cannot take part
  • You are already in, or plan to join, another study of a drug or device that could affect the results

What taking part involves

  • • Your treatment itself is not changed by the registry — it collects information about the Medtronic product you are receiving. Details of what is monitored are not stated — ask the trial team.

Time commitment: Not stated — ask the trial team about how many visits there are, how long it 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
100,000
Started
2012-01
Last checked
2025-12

Plain English Summary

What is this study?

  • • Testing a new treatment for cardiac rhythm disorders
  • • Clinical study - 100,000 participants
  • • The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products

Who can take part?

  • • Adults
  • • Diagnosed with cardiac rhythm disorders

Where?

  • • Barnstaple
  • • Birmingham
  • • Blackpool
  • • Bristol
  • • +13 more UK sites

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

About This Trial

The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.

Cardiac Rhythm DisordersUrological DisordersNeurological DisordersCardiovascular DisordersDigestive DisordersIntracranial AneurysmMechanical Circulatory SupportRespiratory TherapyAortic, Peripheral Vascular and Venous DisordersMinimally Invasive Surgical ProceduresDiagnostic Techniques and ProceduresSurgical Procedures, OperativeRenal InsufficiencyNeurovascularCoronary Artery DiseaseEar, Nose and Throat Disorder

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

What the study is looking for

  • ✓Patient or legally authorized representative provides written authorization and/or consent per institution and...
  • ✓Patient has or is intended to receive or be treated with an eligible Medtronic product
  • ✓Patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment

Who cannot take part

  • ✗Patient who is, or will be, inaccessible for follow-up
  • ✗Patient with exclusion criteria required by local law
  • ✗Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
See the full criteria
Inclusion Criteria: * Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements * Patient has or is intended to receive or be treated with an eligible Medtronic product * Patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment Exclusion Criteria: * Patient who is, or will be, inaccessible for follow-up * Patient with exclusion criteria required by local law * Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

Where Is This Study? (17 UK sites)

Barnstaple, United Kingdom

Recruiting

Birmingham, United Kingdom

Recruiting

Blackpool, United Kingdom

Recruiting

Bristol, United Kingdom

Recruiting

Chelmsford, United Kingdom

ACTIVE_NOT_RECRUITING

Glasgow, United Kingdom

ACTIVE_NOT_RECRUITING

Harrow, 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

Newcastle upon Tyne, United Kingdom

Recruiting

Northampton, United Kingdom

TERMINATED

Sheffield, United Kingdom

Recruiting

Southampton, United Kingdom

Recruiting

How to Get in Touch

Medtronic Product Surveillance Registry

Sponsor contact

CONTACT

rs.productsurveillanceregistry@medtronic.com
Data sourced from ClinicalTrials.gov · Last verified: 2025-12