RecruitingNot ApplicableNCT07455292

Phenotyping Left Ventricle Failure With Hemodynamic Biomarkers From 4D Flow Magnetic Resonance Imaging


Sponsor

IRCCS Policlinico S. Donato

Enrollment

190 participants

Start Date

Oct 13, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses a specialized type of MRI scan called 4D flow MRI—which can visualize blood movement inside the heart in three dimensions over time—to better understand what happens to the heart's pumping function in patients with severe aortic stenosis (a condition where the heart's main valve becomes very narrow). The goal is to find better markers to predict which patients need intervention. **You may be eligible if...** - You are an adult (over 18 years old) - You have been diagnosed with severe narrowing of the aortic heart valve (severe aortic stenosis) - Your doctors have recommended a catheter-based valve replacement procedure called TAVR - You have signed the informed consent form **You may NOT be eligible if...** - You have a metal implant in your body that is not MRI-safe - You have claustrophobia - Your MRI images are of poor quality - You are unwilling to sign the informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTCardiac MRI with 4D Flow acquisition and invasive signal routinely collected during transcatheter aortic valve replacement

Cardiac magnetic resonance imaging, including standard cine imaging and non-contrast 4D Flow MRI acquisition. In the prospective phase, invasive and non-invasive hemodynamic signals routinely collected during the transcatheter aortic valve replacement procedure are recorded for research analysis. No additional procedures beyond standard clinical practice are required. This is a low-intervention interventional study in which all imaging acquisitions and hemodynamic measurements are performed according to standard clinical practice, with no modification of diagnostic or therapeutic pathways.


Locations(2)

IRCCS Policlinico San Donato

San Donato Milanese, Italy

IRCCS Policlinico San Donato

San Donato Milanese, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07455292


Related Trials