RecruitingNAINTERVENTIONAL

BIO|CONCEPT.BIOMONITOR-HF Collect Clinical Data From Heart Failure Patients Using BIOMONITOR Devices With a Study Specific Research Software

This study focuses on people with heart failure who don't have implanted heart devices. Many heart failure patients experience irregular heartbeats, like atrial fibrillation, which can make their condition worse. Researchers are using a gadget called BIOMONITOR IV to track heart activity over time. The main goals are to find out how often these irregular heartbeats occur, and to create a special computer program. This program would help doctors predict when a patient's heart failure might get worse, allowing them to step in early. This could lead to better treatment, fewer hospital stays, and overall improved health for patients.

At a glance

Status

Recruiting

Phase

Sponsor

Biotronik SE & Co. KG

Enrolment target

300

Start

22 Aug 2025

Estimated completion

31 Dec 2028

Heart Failure Arrhythmia Decompensated Heart Failure Atrial Fibrillation

What is this study about?

Heart failure is a serious condition where your heart doesn't pump blood around your body as well as it should. Many people with heart failure also have irregular heartbeats, called arrhythmias. One common type is atrial fibrillation (AF), which can unfortunately make heart failure worse, increasing the risk of serious problems like strokes and even affecting how long someone lives.

Often, when we learn about these irregular heartbeats in heart failure patients, it's from those who have special devices implanted in their chest, like pacemakers or defibrillators. These devices help manage heart rhythms. However, this study is particularly interested in heart failure patients who don't have these implanted devices. We want to understand their heart rhythms better.

To do this, doctors are using a small device called the BIOMONITOR IV. This device is placed under the skin and can track your heart's electrical activity for a long time, from a distance. The researchers hope to discover how often irregular heartbeats happen in these patients. Another important aim is to develop a computer program that can predict when someone's heart failure might take a turn for the worse. If doctors can see this coming, they can offer help sooner, which could mean fewer hospital visits and a better quality of life for patients. The BIOMONITOR IV has also been updated to collect extra information, like fluid levels and breathing patterns, which might offer clues about worsening heart failure.

Key takeaways

This study helps understand heart problems in heart failure patients without implants.
It uses a small, implantable monitor (BIOMONITOR IV) to track heart activity.
Researchers hope to create a tool to predict when heart failure might get worse.
Early prediction could mean earlier treatment and less time in hospital.
You'll have regular check-ups, some in person and some by phone.
You can stop participating at any time.

Who may be eligible?

To join this study, people need to have been diagnosed with heart failure for at least three months, and currently have symptoms that impact their daily activities somewhat (classified as NYHA class II-III). Also, within the last year, you must have either needed to go to hospital because your heart failure got worse, or had changes to your diuretic (water tablet) medication due to worsening heart failure, or had consistently high levels of certain blood markers (NT-proBNP/BNP) that indicate heart strain.

There are also some important reasons why you might not be able to join. For example, if you already have a pacemaker, defibrillator, or another similar device implanted, or if doctors think you need one very soon, you wouldn't be right for this study. Similarly, if you have certain other serious health issues like active cancer treatment, severe kidney problems, or have had a stroke or heart attack recently (within the last three months), you wouldn't be able to take part. This study is also only for adults aged 18 and over, and you should not be involved in another medical device or drug study that could affect 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.

Have I been diagnosed with heart failure for at least 3 months?
Do I have mild to moderate heart failure symptoms that affect my daily life?
Have I had a recent hospital stay or change in diuretics due to worsening heart failure, or high blood tests for heart strain?
Do I NOT have a pacemaker or defibrillator already implanted?
Am I NOT currently receiving treatment for active cancer, or have severe kidney disease?
Am I over 18 years old?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll have the BIOMONITOR IV device gently placed under the skin of your chest during a minor procedure. This device will continuously monitor your heart's activity. You'll also be given a device called a CardioMessenger, which automatically sends the information from your BIOMONITOR to the study team without you needing to do anything. You would need to commit to attending follow-up appointments at the study clinic, and some check-ups might also happen over the phone. The study is designed for long-term monitoring, and the total duration would be discussed with you before you agree to participate.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit could be closer monitoring of your heart health, which might help your doctors understand your condition better over time. However, there are potential risks, such as those associated with the minor procedure to implant the monitor. These are usually small, like a minor bruise or infection at the site. It's really important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Ziekenhuis Oost Limburg AV
Verified postcode
Genk, Belgium· Recruiting
Peter Osypka Herzzentrum
Verified postcode
Munich, Germany· Not yet recruiting

Common questions

What is the BIOMONITOR IV?

It's a small device placed under the skin that tracks your heart's activity for a long time, sending information wirelessly to your doctors.

What is atrial fibrillation?

It's a common type of irregular heartbeat where the upper chambers of your heart beat very fast and irregularly.

Will this study change my current heart medication?

The study itself isn't designed to change your medicines, but your doctors will continue to manage your treatment as usual based on your needs.

How long will I be in the study?

The study involves long-term monitoring. The exact length would be clearly explained by the study team.

What happens to the information collected from my heart?

The data is used by researchers to understand heart failure better and develop new tools to predict worsening conditions. Your personal information will be kept private.

How to find out more

Jan Boergermann, PhD

jan.boergermann@biotronik.com +49 (0) 30 68905 1182 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.