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

RecruitingNAAges 18 Years - anyAllIRCCS Policlinico S. Donato
NCT07455292 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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.
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What it tests

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

2 sites
IRCCS Policlinico San Donato
San Donato Milanese, Italy
IRCCS Policlinico San Donato
San Donato Milanese, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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