Active not recruitingOBSERVATIONAL

Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices

This study is gathering information on people in the UK with heart failure who are having a special device called a Cardiac Resynchronization Therapy (CRT) device fitted. It's like watching how the device helps people in their normal daily lives, rather than in a strict laboratory setting. The main goal is to understand how effective the CRT device is over a long time, how safe it truly is for patients, and whether it improves their health and well-being. Researchers also want to find out if there are any early warning signs for future heart problems and how to make these devices and their settings work even better for patients.

At a glance

Status

Active not recruiting

Sponsor

Biotronik SE & Co. KG

Enrolment target

3,030

Start

14 May 2018

Estimated completion

30 Jun 2026

Heart Failure

What is this study about?

This study is called an 'observational registry'. This means researchers are simply watching and collecting information about what happens during routine care for people with heart failure who are having a specific type of device implanted or updated. This device is called a Cardiac Resynchronization Therapy (CRT) device, and it's used to help the heart pump blood more effectively.

The study aims to understand how well these CRT devices work in the real world, outside of very controlled experimental settings. They want to see how effective they are for patients over a long period, and to make sure they remain safe. By collecting information from many different patients, they hope to get a clear picture of the device's benefits and any potential issues people might experience.

Another important goal is to learn more about heart failure itself. The researchers will be looking for patterns in the patient information that might help predict when someone with heart failure might have a new problem. This could lead to ways to improve the CRT devices and how they are set up to give patients the best possible care.

Key takeaways

This study is about understanding how CRT devices work in real-life for heart failure patients.
It's an 'observational' study, meaning no new treatments, just watching routine care.
The goal is to improve future care for heart failure and CRT device users.
Participants will use a home monitoring device.
It helps identify early signs of heart problems.

Who may be eligible?

To take part in this study, you must be an adult (18 years or older) and either be about to have your first CRT device fitted, or having an existing device upgraded. You should also be able to understand what the study involves and be happy to give your written permission to participate.

Participants will need to use a small device called a CardioMessenger and be willing to have their device monitored remotely from home. This means the healthcare team can keep an eye on your device without you needing to visit the clinic as often.

However, you cannot join if you already have a CRT device fitted from before, or if there's a medical reason why a CRT device isn't suitable for you. You also can't be pregnant or breastfeeding, or taking part in another clinical study that would interfere with this one.

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.

Are you 18 years old or older?
Are you having a new CRT device fitted or an existing one upgraded soon?
Are you able to use a home monitoring device?
Are you NOT pregnant or breastfeeding?
Are you NOT currently part of another clinical study that would conflict with this one?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your doctor will fit or upgrade your CRT device as planned for your heart failure treatment. You will be asked to use a small home monitoring device called a CardioMessenger, which will send information about your heart device to your healthcare team. This remote monitoring allows them to keep track of how your device is working without you needing to visit the clinic as often.

The study involves routine follow-up care that your doctor would provide anyway for your heart condition and device. There are no extra medications or experimental treatments involved beyond your usual care. The duration of your participation will depend on how long your doctor plans to monitor your CRT device, potentially for many years.

Potential risks and benefits

The potential benefit of participating is that the information gathered from your experience, alongside many others, will help researchers better understand CRT devices, leading to improved care for future heart failure patients. There are no additional direct medical benefits to you beyond the standard treatment you would receive. As this is an observational study of routine care, there are no extra medical risks beyond those usually associated with having a CRT device implanted and living with heart failure. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (114)

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

Canberra Heart Rhythm Foundation
Verified postcode
Canberra, Australia
The Canberra Hospital
Verified postcode
Canberra, Australia
Lyell McEwin Hospital
Verified postcode
Elizabeth Vale, Australia
Liverpool Hospital
Verified postcode
Liverpool, Australia
Sydney Adventist Hospital
Verified postcode
Sydney, Australia
Westmead Hospital
Verified postcode
Westmead, Australia
Westmead Private Hosptial
Verified postcode
Westmead, Australia
Kepler Universitätsklinikum
Verified postcode
Linz, Austria
Universitätsklinikum St. Pölten
Verified postcode
Sankt Pölten, Austria
Medizinische Universität Wien
Verified postcode
Vienna, Austria
Imelda Ziekenhuis
Verified postcode
Bonheiden, Belgium
UZ Brussel
Verified postcode
Brussels, Belgium

Common questions

What is a CRT device?

A CRT device is a small pacemaker-like device that helps the heart's chambers beat together in a more coordinated way, making it pump blood more efficiently for people with heart failure.

Will I receive any new treatments in this study?

No, this study only observes the standard care you would receive for your heart failure and CRT device. You won't be given any new or experimental treatments.

What is 'Home Monitoring'?

Home Monitoring means that your heart device can send information wirelessly to your healthcare team from your home using a small device. This allows them to check on your device's performance without you needing to visit the clinic frequently.

How long will I be in the study?

The study will follow you as long as your doctor would typically monitor your CRT device, which could be for a number of years, but you can leave at any time.

Who is running this study?

The study is being run by BIOTRONIK, a company that makes medical devices, and is focused on their CRT devices.