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Long-term Performance of Medtronic Cardiac Devices

This study, called the Product Performance Report, is looking at how well Medtronic's heart devices, like pacemakers and defibrillators (DEVICE), work over a long time. It aims to understand the long-term reliability and performance of these devices in people with heart conditions such as arrhythmia (irregular heartbeat), bradycardia (slow heart rate), heart failure, and sinus tachycardia (fast heart rate). The main goal is to track lead-related complications for each lead model. Anyone can join, regardless of age or gender, as long as they provide informed consent. The study is currently ongoing and plans to enroll 20,000 participants.

Study design
This is an observational study, meaning researchers will watch how the devices perform over time in 20,000 participants. It is not a randomized trial.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from the time their cardiac lead is implanted until they leave the study, pass away, or the device is no longer active.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT00271180

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

Recruiting
Not specifiedAll AgesObservational
Medtronic
~20,000 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:Device

At a glance

Recruiting sites
224 of 333 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Lead related complications for each lead model.
Measured over 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).

Conditions

Arrhythmia
Bradycardia
Heart Failure
Sinus Tachycardia

Explore related trials

ArrhythmiaBradycardiaHeart FailureSinus Tachycardia

NCT00271180

Where you'd take part

This study runs at 333 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • A Coruña

    A Coruña, Spainno site contact published

    Recruiting

  • Aachen

    Aachen, Germanyno site contact published

    Recruiting

  • Ageo

    Ageo, Japanno site contact published

    Recruiting

  • Albuquerque, New Mexico

    Albuquerque, New Mexicono site contact published

    Recruiting

  • Allentown, Pennsylvania

    Allentown, Pennsylvaniano site contact published

    Recruiting

  • Ashkelon

    Ashkelon, Israelno site contact published

    Recruiting

  • Athens

    Athens, Greeceno site contact published

    Recruiting

  • Atlanta, Georgia

    Atlanta, Georgiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Product Performance Report Study Leader · STUDY_CHAIR · Medtronic

Who to contact

Medtronic CRM Clinical Trials
[email protected]
Email the study team

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Eligibility criteria

Inclusion

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

Subjects who are, or will be inaccessible for follow-up
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

What this trial measures

  • Lead related complications for each lead model.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).

    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.