Using 4D Flow MRI to assess left heart pumping in aortic valve stenosis
Tests heart MRI measures of pumping in adults having aortic valve replacement.
Plain-language title generated from the registry record
Registry title: Phenotyping Left Ventricle Failure With Hemodynamic Biomarkers From 4D Flow Magnetic Resonance Imaging
Key facts
- Where
- San Donato Milanese, ItalySee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with severe aortic stenosis who have an indication for transcatheter aortic valve replacement (TAVR). They will have a cardiac MRI with 4D Flow.
- Age
- Adults over 18 years old
- Sex
- All sexes
- Disease stage
- Severe aortic stenosis (defined by ESC guidelines), with normal/high flow or low flow, and an indication for TAVR
Main reasons for not taking part
- Cardiac MRI not possible because of a previous implant with ferromagnetic parts
- Poor MRI image quality that prevents image processing
- Claustrophobia
- Unwilling to sign the informed consent
Read by machine on 12 November 2026.
Where in Italy
- IRCCS Policlinico San DonatoSan Donato Milanese, ItalyContact: Giandomenico Disabato, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- IRCCS Policlinico S. Donato
- Trial code
- NCT07455292
- Record updated
- 6 March 2026
- Original description
This study aims to enhance and streamline intracardiac 4D Flow magnetic resonance imaging (MRI) processing by increasing automation for the quantitative and systematic assessment of left ventricular (LV) dysfunction. The study is designed to achieve the following three objectives.Read full original descriptionShow less
Phenotyping Left Ventricle Failure With Hemodynamic Biomarkers From 4D Flow Magnetic Resonance Imaging
This study aims to enhance and streamline intracardiac 4D Flow magnetic resonance imaging (MRI) processing by increasing automation for the quantitative and systematic assessment of left ventricular (LV) dysfunction. The study is designed to achieve the following three objectives.
The primary objective is to develop a convolutional neural network (CNN)-based deep learning model for the automatic segmentation of the LV endocardial contour throughout the cardiac cycle using intracavitary MRI data. To support model training, a dataset of LV endocardial wall segmentations will be generated from balanced steady-state free precession (bSSFP) images. A purpose-built retrospective MRI database of bSSFP images will be retrieved to accelerate training set creation.
The secondary objective is to develop a numerical framework for non-invasive MRI-based pressure-volume (PV) loop reconstruction and calculation of simplified hemodynamic force descriptors (HDFs). A prospective cohort of patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) will be enrolled. Pre-procedural non-contrast 4D Flow MRI will be acquired, and non-invasive MRI-derived PV loops will be quantitatively compared with invasive catheter-based PV loop measurements. In addition, simplified HDFs will be compared with 4D Flow-derived HDFs to assess their agreement and their potential to elucidate specific features of heart failure-related LV dysfunction.
The tertiary objective is to establish the foundation for a unified, standalone, and clinically deployable framework for comprehensive, automated, and clinician-friendly analysis of LV hemodynamics based on 4D Flow MRI. Internal testing, benchmarking, and structured evaluation by clinical end-users with prior 4D Flow MRI research experience will be conducted to collect feedback and guide further development and clinical translation.
Inclusion: Adult patients (age > 18 years old); Diagnosis of severe AS defined according to ESC guidelines with indication to TAVR; Severe aortic stenosis both in normal/high flow status and in low flow status; Signed informed written consent.
Exclusion: Contraindication to cardiac MRI due to previous implant with ferromagnetic components; Poor MRI quality impairing image post-processing; Claustrophobia; Unwilling to sign the informed consent.