Enhanced Valves Interventions and Safe AI Generated End Results

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMontreal Heart Institute

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Medical imaging analysis via artificial intelligence algorithms

    Diagnostic test

    Development of AI algorithms based on pre-procedural imaging annotations and clinical informations to predict the transcatheter procedural outcomes

Treatment groups

21,000 Participants
are divided into 5 treatment groups
Group A: TAVI1 intervention
Group B: TMVI1 intervention
Group C: TTVI1 intervention
Group D: M-TEER1 intervention
Group E: T-TEER1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Preoperative phase: automated segmentation and measurements compared with manual assessments; Postoperative phase at day 30: comparison of predicted results with actual clinical patient outcomes.

Secondary outcomes

1

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

Time frame
Through study completion, an average of 2 years (retrospective analysis and validation of algorithms).

Other outcomes

1

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.

Time frame
Baseline (pre-procedural) and post-procedural (day 90) analysis

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