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

NCT07455292 | Recruiting

• 1 other identifier: TRANSLATE
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

4D Flow MRI

Outcome Measures

Primary Outcomes (1)

• Accuracy of Automatic Left Ventricular Endocardial Segmentation

  Accuracy of a convolutional neural network (CNN)-based model for automatic delineation of the left ventricular (LV) endocardial contour from short-axis cine balanced steady-state free precession (bSSFP) MRI images throughout the cardiac cycle. Automatically generated contours will be compared with expert manual segmentations (ground truth). Segmentation performance will be quantified using the Dice Similarity Index (DICE) and Hausdorff Distance (HD). Inter- and intra-operator variability of manual segmentation and agreement between manual and automatic contours will also be assessed using Bland-Altman analysis.

  Completion of the retrospective analysis of cardiac MRI datasets (6 months)

Secondary Outcomes (4)

• Agreement Between Non-Invasive MRI-Based and Invasive Pressure-Volume Loop Parameters

  Up to 1 week after TAVR

• Agreement Between Simplified and 4D Flow MRI-Based Hemodynamic Forces

  Up to 1 week after TAVR

• Correlation Between Hemodynamic Forces and LV Volumes

  Up to 1 week after TAVR

• Correlation Between Hemodynamic Forces and LV Global Longitudinal and Circumferential Strain

  Up to 1 week after TAVR

Study Arms (1)

TRANSLATE Study Population

OTHER

The retrospective phase includes adult patients who previously underwent clinically indicated cardiac MRI for left ventricular functional assessment. The prospective phase includes patients with severe aortic stenosis undergoing transcatheter aortic valve replacement, who undergo additional non-contrast 4D Flow MRI and standard invasive hemodynamic measurements as part of routine clinical care. Data from both phases are used for development and validation of automated MRI-based analysis methods.

Diagnostic Test: Cardiac MRI with 4D Flow acquisition and invasive signal routinely collected during transcatheter aortic valve replacement

Interventions

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

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.

Also known as: transcatheter aortic valve implantation, 4D Flow MRI, intracardic invasive pressure, non-invasive blood pressure

TRANSLATE Study Population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (2)

IRCCS Policlinico San Donato

San Donato Milanese, 20097, Italy

RECRUITING

IRCCS Policlinico San Donato

San Donato Milanese, 20097, Italy

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Giandomenico Disabato, MD

  IRCCS Policlinico S. Donato

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giandomenico Disabato, MD

CONTACT

+390252774804; giandomenico.disabato@grupposandonato.it

Francesco Sturla, PhD

CONTACT

+390252774353; francesco.sturla@grupposandonato.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Arm description (retrospective and prospective phases): * retrospective phase includes adult patients who previously underwent clinically indicated cardiac MRI for LV functional assessment; * prospective phase includes patients with severe aortic stenosis undergoing TAVR, who undergo additional non-contrast 4D Flow MRI and standard invasive hemodynamic measurements as part of routine clinical care. Approximately 150 participants will be included in the retrospective phase and up to 40 participants i Intervention Description (prospective phase, low-risk and observational in nature): * cardiac magnetic resonance imaging, including standard cine imaging and non-contrast 4D Flow MRI acquisition; * invasive and non-invasive hemodynamic signals routinely collected during TAVR procedure are recorded for research analys. .

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: March 6, 2026
• Study Start: October 13, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-01

Locations

IT (2)