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

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.

Conditions

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

Interventions

DIAGNOSTIC_TEST

Cardiac 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.

Sponsors & Collaborators

• IRCCS Policlinico S. Donato

  lead OTHER

Principal Investigators

• Giandomenico Disabato, MD · IRCCS Policlinico S. Donato

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-13

Primary Completion

2026-09-30

Completion

2026-09-30

Countries

• Italy

Study Locations