Active not recruitingOBSERVATIONAL

European TauroPace Registry - University of Schleswig-Holstein Prospective Observational Clinical Study

This study, called the European TauroPace Registry, is looking at a treatment called TauroPace for people who are having operations involving heart devices like pacemakers or defibrillators. These devices are called Cardiac Implantable Electronic Devices (CIEDs). The main goal is to understand if TauroPace helps prevent infections related to these heart devices and if it's safe to use. Researchers will gather information from over 2300 such procedures across different hospitals in Europe. This is a long-term study where scientists will observe patients for several years to see the effects of TauroPace. They want to make sure the treatment is both effective and safe for patients receiving these important heart devices.

At a glance

Status

Active not recruiting

Sponsor

University of Kiel

Enrolment target

2,300

Start

22 Feb 2021

Estimated completion

30 Jan 2030

CIED Related Infection

What is this study about?

This study is called the European TauroPace Registry and it's being run by the University of Schleswig-Holstein in Germany. Its main purpose is to learn more about a special treatment called TauroPace when it's used during operations for heart devices. These devices, which include pacemakers and defibrillators, are sometimes called CIEDs (Cardiac Implantable Electronic Devices). People might have these operations for various reasons, such as getting a new device, upgrading an old one, or having parts of it changed or removed.

The researchers want to see how well TauroPace works and whether it helps prevent infections related to these heart devices. They also want to make sure it's safe. This isn't a study where you get a new or untested treatment; TauroPace is used according to its usual instructions. Instead, it's about watching many patients who are already receiving TauroPace to gather important information.

This is a large study, planning to include details from at least 2300 separate procedures. Doctors will collect information about patients' health and the effects of TauroPace over several years. This kind of study helps improve patient care in the future by understanding real-world results of treatments.

Key takeaways

This study helps understand TauroPace's effectiveness for heart device infections.
It's a large European study looking at real-world patient experiences.
Participation involves sharing medical data from your standard care.
There are no new treatments or procedures involved.
You'll be followed for up to 3 years after your first year of treatment.
Your contribution helps improve care for future patients with heart devices.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years old or older. You must also be planning to have an operation involving a heart device (like a pacemaker or defibrillator) where your doctor thinks TauroPace is a suitable treatment for you, based on its official instructions for use.

There are a few reasons why you might not be able to join. If you are under 18 years old, you wouldn't be able to take part. Also, if you aren't able to understand and sign the consent form, either because of physical reasons or if you can't mentally agree to take part, then you wouldn't be included in the study. Essentially, you need to be an adult who can understand and agree to participate.

Quick self-check

Are you 18 years old or older?
Are you having an operation for a heart device (like a pacemaker or defibrillator)?
Has your doctor said TauroPace is suitable for you?
Can you understand and sign a consent form?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, it means that your medical information related to your heart device procedure with TauroPace will be collected by the researchers. This is a "non-interventional" study, which means you won't be given any experimental treatments and the procedures you receive will be based on your doctor's usual care. TauroPace will be used as part of your standard treatment, following its official instructions.

Your journey in the study will involve regular check-ups. Doctors will record information about your health and the device's performance at 3 months and 12 months after your first treatment. After that, they will continue to check in once a year for up to 3 years. These check-ups will continue for as long as you have your heart device. If your heart device is removed, your part in the study would usually end. The study itself is expected to last for about 10 years in total, collecting data from many patients.

Potential risks and benefits

Participating in this study doesn't involve any new treatments or procedures, as TauroPace is used as part of your usual medical care. The potential benefit is that by sharing your health information, you'll be contributing to a better understanding of how TauroPace works in preventing heart device infections, which could help future patients. There are no direct personal medical benefits from taking part, as you would receive TauroPace regardless of study involvement. As with any medical procedure, there are always some risks associated with heart device operations themselves, but these are not increased by being in the study. You have the right to withdraw from the study at any time, without it affecting your medical care.

Locations (8)

Landeskrankenhaus Wiener Neustadt
Wiener Neustadt, Austria
Louis Pradel Hospital
Lyon, France
Krankenhaus Landshut Achdorf
Landshut, Germany
Helios Klinik Cuxhaven
Cuxhaven, Germany
Helios Klinik Wesermarsch
Nordenham, Germany
University Hospital Schleswig-Holstein
Kiel, Germany
Ospedale Regionale San Maurizio
Bolzano, Italy
Great Western Hospitals NHS Foundation Trust
Swindon, United Kingdom

Common questions

What is TauroPace?

TauroPace is a treatment used during heart device operations. This study aims to understand how well it works and if it's safe for preventing infections.

Will I get a new or experimental treatment?

No, you won't. If you take part, TauroPace would be used according to its standard medical instructions, as part of your normal care.

How long will I be followed in the study?

You will have follow-up checks at 3 and 12 months, and then once a year for up to 3 years, or for as long as you have your heart device.

What information will the study collect about me?

Researchers will collect information about your health, your heart device, and how well TauroPace is working to prevent infections, as defined in the study protocol.

Can I leave the study if I change my mind?

Yes, you can. You are free to withdraw from the study at any time, and it will not affect your medical treatment or care.