Active not recruitingOBSERVATIONAL

Micra Transcatheter Pacing System Post-Approval Registry

This study, called the Micra Registry, is looking at a special type of pacemaker called the Micra Transcatheter Pacing System. This tiny pacemaker is designed to help people whose hearts beat too slowly, a condition known as bradycardia. The study aims to confirm how safe and effective the Micra pacemaker is when used by doctors in the real world, after it's been made available to patients. It involves keeping track of patients who receive this pacemaker for a long time, typically at least 9 years. By doing this, researchers can gather important information about its long-term performance and make sure it continues to work as expected for patients. It's like checking in to see how well a new car performs once it's on the road every day.

At a glance

Status

Active not recruiting

Sponsor

Medtronic

Enrolment target

3,100

Start

01 Jul 2015

Estimated completion

01 Apr 2027

Bradycardia

What is this study about?

This research is focused on a very small, advanced type of pacemaker called the Micra Transcatheter Pacing System. Pacemakers are devices that help control your heart rhythm, especially if it's too slow (a condition called bradycardia). Unlike traditional pacemakers that require surgery to implant wires, the Micra pacemaker is placed directly into the heart without the need for wires. This study is being run by Medtronic, the company that makes the Micra pacemaker.

The main goal of this study, known as the Micra Registry, is to carefully watch how the Micra pacemaker works for patients in their daily lives after it's been approved for use. Researchers want to make sure it's consistently safe and effective, just as it was in earlier tests. By observing many patients over a long period, they can gather robust information about its performance, potential challenges, and overall benefits in a wide range of real-world situations.

Think of it like this: when a new medicine or device is approved, it has already gone through rigorous testing. However, ongoing studies like this registry continue to monitor its performance in a larger and more varied group of people over a longer time. This helps doctors and patients feel even more confident about its long-term safety and how well it helps manage conditions like a slow heartbeat.

Key takeaways

This study tracks the Micra pacemaker after it's used in real patients.
It checks how safe and well the tiny pacemaker works over many years.
The study is for people needing a Micra pacemaker due to a slow heart rate (bradycardia).
You'll have regular follow-up visits, usually once a year, for at least 9 years.
Participating helps gather important long-term information about the device.
You can stop participating at any time without affecting your medical care.

Who may be eligible?

To be considered for this study, you would need to be planning to have a Micra Transcatheter Pacing System fitted. It's important to join the study before you have this procedure.

You also need to be able to give your clear permission to take part, either yourself or through someone legally appointed to make decisions for you. This is a standard requirement for all medical studies.

If you are currently involved in another medical study involving a new drug or device, or if you plan to be, you might not be able to join this one. This is to make sure that the results of this study are clear and not confused by other treatments. Also, if there's a reason doctors think it might be difficult to keep in touch with you for follow-up appointments, you might not be able to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am planning to have a Micra Transcatheter Pacing System implanted.
I can provide my informed consent, or a legally authorised person can do so for me.
I am able and willing to attend follow-up appointments for many years.
I am not currently or planning to be in another study that might affect this research.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be followed for a long time – typically for at least 9 years, or until the study ends. You'll have regular check-ups, usually once a year, to see how you and your Micra pacemaker are doing.

If your doctor normally sees you more often for your heart condition, those extra visits will also be reported as part of the study. All information about your Micra pacemaker check-ups will be collected. The total time this study expects to run for all patients is about 11 years, during which your health and the pacemaker's performance will be monitored.

Potential risks and benefits

Taking part in this study means your health and the performance of your Micra pacemaker will be closely monitored, which could provide you with reassurance about your device. There's no direct treatment happening in the study beyond you receiving the Micra pacemaker as planned by your doctor; it's mostly about collecting information. As with any medical device, there are always potential risks associated with the Micra pacemaker itself, which your doctor will discuss with you. Any new or unexpected health issues will also be recorded. You are free to withdraw from the study at any time without affecting your medical care.

Locations (156)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Birmingham, United States
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Los Angeles, United States
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Redwood City, United States
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New Haven, United States
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Washington D.C., United States
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Clearwater, United States
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Jacksonville, United States
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Safety Harbor, United States
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Atlanta, United States
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Indianapolis, United States
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West Des Moines, United States
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Kansas City, United States

Common questions

What exactly is bradycardia?

Bradycardia means your heart beats too slowly. This can make you feel tired, dizzy, or short of breath because your body isn't getting enough oxygen-rich blood.

What is a Micra Transcatheter Pacing System?

It's a very small, leadless pacemaker that is implanted directly into your heart to help it beat at a normal rate if you have bradycardia. Unlike traditional pacemakers, it doesn't need wires (leads).

Why is this study being done if the pacemaker is already approved?

Even after approval, it's important to keep checking how new devices work in a larger number of patients over many years in everyday medical practice. This helps ensure its long-term safety and effectiveness.

Will I receive any new treatment in this study?

No, this study is observational. You will receive the Micra pacemaker as decided by your doctor for your health needs. The study simply collects information about your health and how the pacemaker works after it's been implanted.

How long will I be followed in the study?

You will be followed for at least 9 years, or until the study finishes. You'll have yearly check-ups, and any other regular visits you have with your doctor for your heart condition will also be noted.