Status:
RECRUITING
Enhanced Valves Interventions and Safe AI Generated End Results
Lead Sponsor:
Montreal Heart Institute
Collaborating Sponsors:
Centre Hospitalier Universitaire de Bordeaux, FRANCE
Materialise
Conditions:
Heart Valve Disease
TAVI
Eligibility:
All Genders
18+ years
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 ret...
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, includ...
Eligibility Criteria
Inclusion
- 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:
- 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
- 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
- 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
Key Trial Info
Start Date :
May 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2029
Estimated Enrollment :
21000 Patients enrolled
Trial Details
Trial ID
NCT07213531
Start Date
May 1 2024
End Date
May 1 2029
Last Update
October 9 2025
Active Locations (15)
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1
Montefiore Medical Center New York
New York, New York, United States, 10467
2
Montreal Heart Institute, 5000 Rue Bélanger, Montréal
Montreal, Quebec, Canada, H1T 1C8
3
St Michael's Hospital Toronto
Toronto, Canada
4
St Paul's Hospital Vancouver
Vancouver, Canada