Not yet recruitingOBSERVATIONAL

An International Multicenter, Multivendor Evaluation of the Free-Running Framework for Cardiac Function

Researchers are testing a new way to do heart MRI scans, called the Free-Running Framework (FRF). Current heart MRIs require you to hold your breath many times and have sticky pads on your chest. This new method aims to remove these steps, making the scan easier and faster, especially for people who find traditional scans difficult. The study wants to see if this new scan provides the same detailed information about your heart as the standard method. If successful, it could mean quicker, more comfortable, and more accurate heart scans in the future. Up to 300 adults with heart conditions will take part in this international study between 2026 and 2031.

At a glance

Status

Not yet recruiting

Sponsor

Matthias Stuber

Enrolment target

300

Start

01 Jun 2026

Estimated completion

01 Sep 2030

Congenital Heart Diseases Cardiac Diseases

What is this study about?

Heart disease is a major health concern, and getting a clear picture of your heart is really important for doctors to understand and treat it. One of the best ways to do this is with an MRI scan. An MRI is a special type of scan that uses magnets and radio waves to create detailed images of your heart without using X-rays.

However, current heart MRI scans can be quite long and tricky. You often have to hold your breath many times, and electrodes (small sticky pads) are placed on your chest to monitor your heartbeat. These steps help the scanner get clear images of your heart as it moves. This can be difficult for some people, especially if they have serious heart conditions or find it hard to stay still or hold their breath.

This study is testing a new MRI technique called the Free-Running Framework (FRF). The idea behind FRF is to make heart scans much simpler and faster. With this new method, you wouldn't need to hold your breath, and you wouldn't need the sticky pads on your chest. Instead, the scanner continuously gathers information and then puts it all together to create a 3D image of your entire heart. This could mean more comfortable scans, less time in the scanner, and potentially more reliable results for doctors. The main goal of this study is to confirm that this new FRF method gives the same accurate information about your heart as the traditional scan.

Key takeaways

Tests a new, easier heart MRI method.
Aims to skip breath-holding and chest electrodes.
Compares new scan to standard MRI to ensure accuracy.
Could lead to quicker, more comfortable heart scans.
For adults with heart conditions already needing an MRI.
Involves an extra scan during your regular MRI appointment.

Who may be eligible?

This study is looking for adults aged 18 or older who have been diagnosed with a heart condition and are already scheduled to have a heart MRI scan. You need to be able to understand the study information and agree to take part. If you’re a minor and your local laws allow it, you might be able to join with a parent or guardian's permission.

It's important that you are able to safely have an MRI scan, meaning you shouldn't have anything in your body that isn't safe for an MRI, like certain types of pacemakers or metal implants. You also shouldn't be severely claustrophobic (fear of small spaces) to the point where you couldn’t complete the scan.

If you have any conditions that make it hard to stay still or if you can't have the special dye (contrast agent) sometimes used in MRIs, then this study might not be suitable for you.

Quick self-check

Are you 18 years old or older?
Do you have a heart condition and are already scheduled for a heart MRI?
Can you safely have an MRI (e.g., no incompatible metal implants)?
Are you able to understand study instructions and give your permission to be in the study?

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

What does participation involve?

If you decide to take part in this study, you will have your usual heart MRI scan, but with an additional scan using the new 'Free-Running Framework' method. Both scans will happen during the same visit. You won't need to take any new medications. The total time for your MRI appointment might be a bit longer than a standard scan, possibly to allow for the additional FRF scan. The researchers will make sure you understand all instructions. You'll be asked to provide your written consent before participating, and you'll be informed if any unexpected findings are discovered during your scan. The study will run between 2026 and 2031, involving up to 300 people in total.

Potential risks and benefits

Participating in this study will help researchers understand if this new heart MRI technique is as good as the standard one. Any potential benefits are for future patients, as this study is mainly to confirm the new method works well. While MRI scans are generally safe, there are very few risks, such as possible reactions to the contrast dye if used, or discomfort from lying still. Your safety is very important, and you will be carefully screened to ensure an MRI is safe for you. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (20)

University of California, Los Angeles
Los Angeles, United States
Emory University
Atlanta, United States
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, United States
Boston's Children Hospital
Boston, United States
Mayo Clinic
Rochester, United States
Washington University in St. Louis
St Louis, United States
Ohio State University
Columbus, United States
Children's Hospital of Philadelphia
Philadelphia, United States
UT Southwestern Medical Center
Dallas, United States
University of Melbourne
Melbourne, Australia
Fundacion Cardioinfantil-LaCardio
Bogotá, Colombia
University of Bonn
Bonn, Germany

+8 more sites — see the official record for the full list.

Common questions

What is the main goal of this study?

The main goal is to check if a new heart MRI technique, which is simpler and quicker, gives the same accurate information as the standard heart MRI scan.

Will I have to hold my breath during the scan?

No, with this new method being tested, you would not need to hold your breath. This is one of the key improvements it aims to offer.

How long will the MRI scan take if I join the study?

The study aims for quicker scans overall. However, because you'll have an additional scan for the study, your appointment might be slightly longer than a regular MRI to allow for both scans.

Do I need to take any new medicines for this study?

No, you will not need to take any new medicines as part of this study.

What happens if the researchers find something unexpected on my scan?

If the researchers find anything that needs medical attention, they will inform you.

How to find out more

Katerina Eyre, PhD

katerina.eyre@chuv.ch +41213147513 Official trial record

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