NCT07213531

Enhanced Valves Interventions and Safe AI Generated End Results

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 21,000 (estimated)
• Sponsor: Montreal Heart Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The ENVISAGE study is a non-interventional, retrospective research study designed to validate an artificial intelligence (AI)-based framework for the automated analysis of cardiac imaging data, including multi-slice cardiac computed tomography (CT) and transesophageal echocardiography (TEE). The primary objective is to predict the success of transcatheter heart valve interventions, including aortic, mitral, and tricuspid valve interventions (TAVI, TMVI, M-TEER, T-TEER). The AI framework developed in this study will rely on deep learning algorithms, particularly convolutional neural networks (CNNs) and other advanced models, to automatically segment critical anatomical structures and perform accurate measurements of these structures from CT and TEE images. These measurements will then be combined with pre-interventional clinical data to optimize patient selection and intervention planning, as well as to predict surgical outcomes with high accuracy. AI will also aim to reduce human error and inter-observer variability in the interpretation of cardiac images, which could significantly improve clinical outcomes.

Conditions

• Heart Valve Disease
• TAVI
• M-TEER
• TTVI
• TMVI
• T-TEER
• Mitraclip
• TriClip

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Medical imaging analysis via artificial intelligence algorithms	Development of AI algorithms based on pre-procedural imaging annotations and clinical informations to predict the transcatheter procedural outcomes

Timeline

• Start date: 2024-05-01
• Primary completion: 2028-05-01
• Completion: 2029-05-01
• First posted: 2025-10-09
• Last updated: 2025-10-09

Locations

15 sites across 5 countries: United States, Canada, France, Germany, Italy