About this trial
This non-interventional study aims to use artificial intelligence to improve the prediction of transcatheter heart valve interventions and optimize patient outcomes. It is based on the analysis of retrospective data from various specialized centers worldwide.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
five to ten image volumes at cardiac phases from 5% to 95% R-R
0.625 mm slice thickness
0.625 mm spacing between slices
0.88 mm in-plane pixel spacing
Disqualifiers
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
Trial population
Patients with heart valve disease eligible for transcatheter interventions (TAVI, M-TEER, TMVI, TTVI).
Trial design
Cohort
Retrospective
Treatments tested in this trial
Medical imaging analysis via artificial intelligence algorithms
Diagnostic testDevelopment of AI algorithms based on pre-procedural imaging annotations and clinical informations to predict the transcatheter procedural outcomes
Treatment groups
Trial outcomes
Primary outcomes
Accuracy of transcatheter AI predictions
Validation of artificial intelligence algorithms for automatic segmentation of anatomic structures and imaging measurements, and prediction of the success of transcatheter interventions. Output of AI algorithm: * Sizes, types, and number of devices to be implanted * Device success * Percentage risk of permanent pacemaker implantation (for TAVI and TTVI) * Percentage risk of 30-day (para)valvular regurgitation for TAVI, and residual regurgitation for M-TEER and T-TEER * Single leaflet detachment for M-TEER and T-TEER * Left ventricular outflow tract obstruction for TMVI. Key success indicators: * First, independent retrospective validation dataset AI algorithms predict procedural outcome with \>90% accuracy and low inter-reader observer variability when compared to measured procedural outcome. * Second independent retrospective dataset, perform a study to validate AI algorithms with \>90% accuracy and low inter-reader observer variability when compared to measured procedural outcome.
Secondary outcomes
Performance of AI algorithms in CT and TEE image analysis
Development and evaluation of AI algorithm training platform for data analysis of patients undergoing transcatheter valve procedures. Comparison of AI model performance with existing benchmarks and manual analyses
Other outcomes
AI-based discovery of clinical knowledge for patient selection
Comparison of AI's ability to standardize patient selection, treatment planning and clinical outcomes with traditional methods. Assessment of accuracy in predicting patient outcomes and reducing procedure-specific complications.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Montreal Heart Institute
Lead sponsor
Centre Hospitalier Universitaire de Bordeaux, FRANCE
Collaborator
Materialise
Collaborator
Pie Medical Imaging
Collaborator
Clinique Pasteur Toulouse
Collaborator
Centre Cardiologique du Nord
Collaborator
Rennes University Hospital
Collaborator
San Raffaele University Hospital, Italy
Collaborator
Istituto clinico Città di Brescia
Collaborator
Unity Health Toronto
Collaborator
University Hospital, Marseille
Collaborator
University Hospital, Lille
Collaborator
Hospitaux Universitaires Paris Sud
Collaborator
Montefiore Medical Center
Collaborator
University Medical Center Mainz
Collaborator
Universitätsklinikum Hamburg-Eppendorf
Collaborator
Vancouver Hospital
Collaborator