Using AI to improve planning for transcatheter heart valve procedures

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

This is a non-interventional, retrospective, multicenter project that applies deep learning (including convolutional neural networks) to multi-slice cardiac CT and vendor-specific transesophageal echocardiography to automate segmentation and measurements. The AI framework combines these imaging-derived measurements with pre-procedural clinical data to predict procedural success for TAVI, TMVI, TTVI, and M-TEER. The work aims to standardize measurements, reduce inter-observer variability, and support patient selection and procedural planning. Data are collected from specialized centers worldwide and processed centrally for validation of the predictive models.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Patients who have reached the age of legal majority under local laws.

* For TAVI group: All patients who have had TAVI with a third generation transcatheter heart valve (THV), with an available pre-procedural optimal quality CT scan as defined by an ECG- gating CT with:

  1. five to ten image volumes at cardiac phases from 5% to 95% R-R
  2. 0.625 mm slice thickness
  3. 0.625 mm spacing between slices
  4. 0.88 mm in-plane pixel spacing
* For TMVI group: Patients who have had a TMVI with a dedicated device and screen failures, with an available optimal quality CT scan.
* For TTVI group: Patients who have had a TTVI with a dedicated device and screen failures, with an available optimal quality CT scan.
* For M-TEER: All patient who have had a M-TEER with 1) G4 or newer iteration of MitraClip or 2) G2 or newer iteration of Pascal, with available pre-procedural TEE videos images from one of two vendors: Phillips or GE, with clear identifiable views of the Mitral valve, frame per second equal or higher than 40 frames per second, acceptable 3D reconstructions.
* For T-TEER: All patient who have had a T-TEER with G4 or newer iteration of TriClip or 2) G2 or newer iteration of Pascal, with available pre-procedural TEE videos images from one of two vendors: Phillips or GE, with clear identifiable views of the Tricuspid valve, frame per second equal or higher than 40 frames per second, acceptable transgastric image with acceptable 3D reconstructions.

Exclusion Criteria:

* For TAVI group: Valve-in-valve procedures
* For TMVI group: Valve-in-valve and valve-in-ring procedures
* For TTVI: Valve-in-valve and valve-in-ring procedures
* For M-TEER: G3 or older MitraClip, G1 Pascal
* For T-TEER: G3 Triclip, G1 Pascal

Where it's running

• Montefiore Medical Center New York
  New York, New York, United States Recruiting
• Montreal Heart Institute, 5000 Rue Bélanger, Montréal
  Montreal, Quebec, Canada Recruiting
• St Michael's Hospital Toronto
  Toronto, Canada Recruiting
• St Paul's Hospital Vancouver
  Vancouver, Canada Recruiting
• Centre Hospitalier Universitaire (CHU) de Bordeaux, 12 rue Dubernat 33404 Talence cedex
  Bourdeaux, France Recruiting
• CHU Lille
  Lille, France Recruiting

Study contacts

• Principal investigator: Thomas Modine, MD, PhD — University Hospital Bordeaux, France
• Study coordinator: Thomas Modine, MD, PhD
• Email: thomasmodine@gmail.com
• Phone: +33(0)5 25 377541

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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.