RecruitingNCT07213531
Enhanced Valves Interventions and Safe AI Generated End Results
Sponsor
Montreal Heart Institute
Enrollment
21,000 participants
Start Date
May 1, 2024
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria10
- 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
- mm slice thickness
- mm spacing between slices
- 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 Criteria5
- 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
Interventions
DIAGNOSTIC_TESTMedical 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
Locations(15)
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NCT07213531