Actively Recruiting

Age: 18Years +
All Genders
NCT07213531

Enhanced Valves Interventions and Safe AI Generated End Results

Led by Montreal Heart Institute · Updated on 2025-10-09

21000

Participants Needed

15

Research Sites

260 weeks

Total Duration

On this page

Sponsors

M

Montreal Heart Institute

Lead Sponsor

C

Centre Hospitalier Universitaire de Bordeaux, FRANCE

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Enhanced Valves Interventions and Safe AI Generated End Results

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who have reached the legal age of majority under local laws
  • For TAVI group: Patients who had TAVI with a third generation transcatheter heart valve and have an optimal quality pre-procedural CT scan meeting specific imaging parameters
  • For TMVI group: Patients who had TMVI with a dedicated device and have an optimal quality CT scan
  • For TTVI group: Patients who had TTVI with a dedicated device and have an optimal quality CT scan
  • For M-TEER group: Patients who had M-TEER with G4 or newer MitraClip or G2 or newer Pascal, with available pre-procedural TEE video images from Phillips or GE showing clear mitral valve views, at least 40 frames per second, and acceptable 3D reconstructions
  • For T-TEER group: Patients who had T-TEER with G4 or newer TriClip or G2 or newer Pascal, with available pre-procedural TEE video images from Phillips or GE showing clear tricuspid valve views, at least 40 frames per second, and acceptable 3D reconstructions including transgastric images
Not Eligible

You will not qualify if you...

  • For TAVI group: Valve-in-valve procedures
  • For TMVI group: Valve-in-valve and valve-in-ring procedures
  • For TTVI group: Valve-in-valve and valve-in-ring procedures
  • For M-TEER group: Use of G3 or older MitraClip or G1 Pascal devices
  • For T-TEER group: Use of G3 TriClip or G1 Pascal devices

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 15 locations

1

Montefiore Medical Center New York

New York, New York, United States, 10467

Actively Recruiting

2

Montreal Heart Institute, 5000 Rue Bélanger, Montréal

Montreal, Quebec, Canada, H1T 1C8

Actively Recruiting

3

St Michael's Hospital Toronto

Toronto, Canada

Actively Recruiting

4

St Paul's Hospital Vancouver

Vancouver, Canada

Actively Recruiting

5

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

Bourdeaux, France, 33404

Actively Recruiting

6

CHU Lille

Lille, France

Actively Recruiting

7

CHU Marseille

Marseille, France

Actively Recruiting

8

Centre Cardiologique du Nord Paris

Paris, France

Actively Recruiting

9

Institut Cardiovasculaire Paris-Sud Paris

Paris, France

Actively Recruiting

10

Centre Hospitalier Universitaire Rennes

Rennes, France

Actively Recruiting

11

Clinque Pasteur Toulouse - France

Toulouse, France

Actively Recruiting

12

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Actively Recruiting

13

Heart Valve Center Mainz

Mainz, Germany

Actively Recruiting

14

Istituto Clinico Città di Brescia

Brescia, Italy

Actively Recruiting

15

San Raffaele Heart Valve Center Milan

Milan, Italy

Actively Recruiting

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Research Team

T

Thomas Modine, MD, PhD

CONTACT

W

Walid Ben Ali, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

5

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