Enhanced Valves Interventions and Safe AI Generated End Results
Trial ID: NCT07213531
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2024-05-01
Completion date: 2029-05
Sponsor: Montreal Heart Institute
Collaborators: Centre Hospitalier Universitaire de Bordeaux, FRANCE; Materialise; Pie Medical Imaging; Clinique Pasteur Toulouse; Centre Cardiologique du Nord; Rennes University Hospital; San Raffaele University Hospital, Italy; Istituto clinico Città di Brescia; Unity Health Toronto; University Hospital, Marseille; University Hospital, Lille; Hospitaux Universitaires Paris Sud; Montefiore Medical Center; University Medical Center Mainz; Universitätsklinikum Hamburg-Eppendorf; Vancouver Hospital
Conditions: Heart Valve Disease; TAVI; M-TEER; TTVI; TMVI; T-TEER; Mitraclip; TriClip
Interventions: Medical imaging analysis via artificial intelligence algorithms
Locations: Montefiore Medical Center New York; Montreal Heart Institute, 5000 Rue Bélanger, Montréal; St Michael's Hospital Toronto; St Paul's Hospital Vancouver; Centre Hospitalier Universitaire (CHU) de Bordeaux, 12 rue Dubernat 33404 Talence cedex; CHU Lille; CHU Marseille; Centre Cardiologique du Nord Paris; Institut Cardiovasculaire Paris-Sud Paris; Centre Hospitalier Universitaire Rennes; Clinque Pasteur Toulouse - France; University Medical Center Hamburg-Eppendorf; Heart Valve Center Mainz; Istituto Clinico Città di Brescia; San Raffaele Heart Valve Center Milan
Countries: United States; Canada; Canada; Canada; France; France; France; France; France; France; France; Germany; Germany; Italy; Italy
Enrollment: 21000
Age range: 18 Years - None
Sex: ALL

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 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

Outcomes:
Accuracy of transcatheter AI predictions