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ClinicalTrials.gov ID

NCT07213531

Lead Sponsor

Montreal Heart InstituteOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

21,000Estimated

Last Update Posted

Oct 9, 2025Actual

Start Date

May 1, 2024Actual

Primary Completion Date

May 2028Estimated

Completion Date

May 2029Estimated

Official Title

Enhanced Valves Interventions and Safe AI Generated End Results

Brief 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.

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

• Medical imaging analysis via artificial intelligence algorithms

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Observational Model

Cohort

Time Perspective

Retrospective

Lead Sponsor

Montreal Heart InstituteOTHER

Collaborators

Centre Hospitalier Universitaire de Bordeaux, FRANCEUNKNOWN

MaterialiseINDUSTRY

Pie Medical ImagingUNKNOWN

Clinique Pasteur ToulouseOTHER

Centre Cardiologique du NordOTHER

Rennes University HospitalOTHER

San Raffaele University Hospital, ItalyOTHER

Istituto clinico Città di BresciaUNKNOWN

Unity Health TorontoOTHER

University Hospital, MarseilleOTHER

University Hospital, LilleOTHER

Hospitaux Universitaires Paris SudUNKNOWN

Montefiore Medical CenterOTHER

University Medical Center MainzOTHER

Universitätsklinikum Hamburg-EppendorfOTHER

Vancouver HospitalUNKNOWN

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