ENVISAGE
Enhanced Valves Interventions and Safe AI Generated End Results
AI Description
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.
- Who can join
- adult, older adult
- Participants
- 21000
- Expected completion
- 2029-05
- Funded by
- other
Conditions studied
Heart Valve Disease, M-TEER, Mitraclip, T-TEER, TAVI, TMVI, TTVI, TriClip
What is being tested
- DIAGNOSTIC_TEST: Medical imaging analysis via artificial intelligence algorithms
What it measures
- 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., Preoperative phase: automated segmentation and measurements compared with manual assessments; Postoperative phase at day 30: comparison of predicted results with actual clinical patient outcomes.
Working with
Centre Cardiologique du Nord, Centre Hospitalier Universitaire de Bordeaux, FRANCE, Clinique Pasteur Toulouse, Hospitaux Universitaires Paris Sud, Istituto clinico Città di Brescia, Materialise, Montefiore Medical Center, Pie Medical Imaging, Rennes University Hospital, San Raffaele University Hospital, Italy, Unity Health Toronto, University Hospital, Lille, University Hospital, Marseille, University Medical Center Mainz, Universitätsklinikum Hamburg-Eppendorf, Vancouver Hospital
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Registry entry updated 2025-10-09
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.