Using 4D Flow MRI to characterize left ventricular failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study uses a retrospective arm to build an anonymized database of short-axis bSSFP cine images with manually corrected LV endocardial contours and a prospective arm to acquire non-contrast 4D Flow MRI before TAVR. A convolutional neural network (e.g., ResNet) will be trained on the retrospective dataset (approximately 75% training, 25% test) to automate LV endocardial segmentation throughout the cardiac cycle. The prospective cohort will undergo 4D Flow MRI and routine invasive monitoring during TAVR to enable non-invasive pressure–volume loop reconstruction and calculation of simplified hemodynamic force descriptors. Automated MRI outputs will be benchmarked against manual segmentations and invasive signals to validate accuracy and support translational implementation.

Why it matters

Who can join: the full rules

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.

Where it's running

• IRCCS Policlinico San Donato
  San Donato Milanese, Italy Recruiting
• IRCCS Policlinico San Donato
  San Donato Milanese, Italy Recruiting

Study contacts

• Principal investigator: Giandomenico Disabato, MD — IRCCS Policlinico S. Donato
• Study coordinator: Giandomenico Disabato, MD
• Email: giandomenico.disabato@grupposandonato.it
• Phone: +390252774804

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.