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.

Conditions

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

Intervention / Treatment

• Diagnostic Test: Medical imaging analysis via artificial intelligence algorithms

Primary Outcome Measures

• Accuracy of transcatheter AI predictions (Preoperative phase: automated segmentation and measurements compared with manual assessments; Postoperative phase at day 30: comparison of predicted results with actual clinical patient outcomes.)
  Validation of artificial intelligence algorithms for automatic segmentation of anatomic structures and imaging measurements, and prediction of the success of transcatheter interventions. Output of AI algorithm: * Sizes, types, and number of devices to be implanted * Device success * Percentage risk of permanent pacemaker implantation (for TAVI and TTVI) * Percentage risk of 30-day (para)valvular regurgitation for TAVI, and residual regurgitation for M-TEER and T-TEER * Single leaflet detachment for M-TEER and T-TEER * Left ventricular outflow tract obstruction for TMVI. Key success indicators: * First, independent retrospective validation dataset AI algorithms predict procedural outcome with \>90% accuracy and low inter-reader observer variability when compared to measured procedural outcome. * Second independent retrospective dataset, perform a study to validate AI algorithms with \>90% accuracy and low inter-reader observer variability when compared to measured procedural outcome.

Countries

Canada, France, Germany, Italy, United States

Locations and Investigators

• Montefiore Medical Center New York, New York, United States (Recruiting)
  • Andrea Scotti, MD, PhD
• Montreal Heart Institute, 5000 Rue Bélanger, Montréal, Montreal, Canada (Recruiting)
  • Walid Ben Ali, MD, PhD
  • Walid Ben Ali, MD, PhD (Principal Investigator)
• St Michael's Hospital Toronto, Toronto, Canada (Recruiting)
  • Neil Fam, MD
• St Paul's Hospital Vancouver, Vancouver, Canada (Recruiting)
  • John Webb, MD
• Centre Hospitalier Universitaire (CHU) de Bordeaux, 12 rue Dubernat 33404 Talence cedex, Bourdeaux, France (Recruiting)
  • Lionel Leroux, MD
  • Thomas Modine, MD, PhD (Principal Investigator)
• CHU Lille, Lille, France (Recruiting)
  • Augustin Coisne, MD, PhD
• CHU Marseille, Marseille, France (Recruiting)
  • Thomas Cuisset, MD, PhD
• Centre Cardiologique du Nord Paris, Paris, France (Recruiting)
  • Julien Dreyfus, MD, PhD
• Institut Cardiovasculaire Paris-Sud Paris, Paris, France (Recruiting)
  • Myriam Akodad, MD
• Centre Hospitalier Universitaire Rennes, Rennes, France (Recruiting)
  • Erwan Donal, MD, PhD
• Clinque Pasteur Toulouse - France, Toulouse, France (Recruiting)
  • Didier Tchétché, MD
• University Medical Center Hamburg-Eppendorf, Hamburg, Germany (Recruiting)
  • Lenard Conradi, MD, PhD
• Heart Valve Center Mainz, Mainz, Germany (Recruiting)
  • Ralph Stephan von Bardeleben, MD, PhD
• Istituto Clinico Città di Brescia, Brescia, Italy (Recruiting)
  • Marianna Adamo, MD, PhD
• San Raffaele Heart Valve Center Milan, Milan, Italy (Recruiting)
  • Francesco Maisano, MD, PhD

Study Officials

• Thomas Modine, MD, PhD (Principal Investigator) — University Hospital Bordeaux, France
• Walid Ben Ali, MD, PhD (Principal Investigator) — Montreal Heart Institute