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)

Montefiore Medical Center New York

New York, New York, United States

Montreal Heart Institute, 5000 Rue Bélanger, Montréal

Montreal, Quebec, Canada

St Michael's Hospital Toronto

Toronto, Canada

St Paul's Hospital Vancouver

Vancouver, Canada

Centre Hospitalier Universitaire (CHU) de Bordeaux, 12 rue Dubernat 33404 Talence cedex

Bourdeaux, France

CHU Lille

Lille, France

CHU Marseille

Marseille, France

Centre Cardiologique du Nord Paris

Paris, France

Institut Cardiovasculaire Paris-Sud Paris

Paris, France

Centre Hospitalier Universitaire Rennes

Rennes, France

Clinque Pasteur Toulouse - France

Toulouse, France

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Heart Valve Center Mainz

Mainz, Germany

Istituto Clinico Città di Brescia

Brescia, Italy

San Raffaele Heart Valve Center Milan

Milan, Italy

View Full Details on ClinicalTrials.gov

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NCT07213531