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

Conditions

• Cardiac Diseases
• Congenital Heart Diseases

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Study Details

This project aims to evaluate a new cardiac MRI technique called the Free-Running Framework (FRF), which could simplify and accelerate the process of acquiring cardiac images. The investigators want to verify whether this method can provide functional heart measurements comparable to those obtained with traditional methods. More specifically, the goal of the study is to compare the measurements obtained with FRF to those obtained with standard sequences, to ensure they match and that this new approach can be reliably used in clinical practice. The FRF technique works differently from standard cardiac MRI. In standard exams, patients are asked to hold their breath several times and small electrodes (ECG) are used to monitor the heartbeat during the scan. These steps are needed to get clearer images of the heart as it moves. With FRF, these steps are no longer necessary: the scan is performed while patients' breath normally and without ECG monitoring. In addition, standard MRI takes multiple 2D slices of the heart, one after another. The FRF method instead captures a 3D image of the entire heart in one go, which can improve the consistency of the exam and reduce errors when doctors analyze the images later. This is all possible because the FRF method records data continuously and then organizes the images afterward based on how participants heart and breathing were moving during the exam. This helps the imager to get clear images of the heart, even without breath-holding or ECG monitoring. This project is aimed at individuals with heart disease who require cardiac MRI exams to monitor their health status (age ≥ 18 years) and are able to clearly understand the instructions provided by the research team. The investigators have already conducted small-scale technical and feasibility studies using FRF. These studies have shown that FRF is easy to use, faster than traditional methods, and provides image quality comparable to standard imaging techniques. The investigators now wish to evaluate its use in a clinical setting. More specifically, the investigators need to verify that FRF provides the same essential diagnostic information as standard techniques, so that it can be reliably used in future patient care. A maximum of 300 participants will be included in the investigation of this MRI technique between 2026 and 2031. This is a multi-center study, conducted internationally across 18 centers. This project is being carried out in compliance with Swiss legislation. The investigators follow all internationally recognized guidelines. The competent ethics committee has reviewed and approved this project.

Key Dates

Start date

Jun 30, 2026

Status verified

Apr 2026

Primary completion

Jan 31, 2028

Completion

Sep 30, 2030

Study Design

Enrollment

300 participants (estimated)

Arms

• Arm: Patients with congenital heart disease
  FAST-CMR will evaluate the technique's performance in complex, heterogeneous anatomy.
• Arm: Patients unable to perform breath-holding
  including those with advanced heart failure, pulmonary hypertension, or chronic obstructive pulmonary disease (COPD), representing a subgroup where conventional breath-held CMR techniques are often suboptimal or not feasible.
• Arm: Other cardiovascular disease patients who are able to perform breath-holding
  This group represents the standard patient population for whom conventional CMR is currently optimized.

Primary Outcome Measure

mean paired difference (bias) in left ventricular ejection fraction (LVEF) between 5D FISS-FRF and conventional 2D cine CMR [ Time Frame: Baseline (during study MRI acquisition) ]

Central Contacts

• Katerina Eyre, PhD
  +41213147513
  [email protected]
• Matthias Stuber, PhD
  +41213147534
  [email protected]

Locations (9)

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