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

Aortic Valve Stenosis Left Ventricle Function Transcatheter Aortic Valve Replacement (TAVR)

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

Inclusion Criteria4

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 Criteria4

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.

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.