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NCT07213531Recruiting

Enhanced Valves Interventions and Safe AI Generated End Results

Montreal Heart Institute

Start Date

5/1/2024

Completion Date

5/1/2029

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.

Detailed Description

The ENVISAGE study is a non-interventional, retrospective research study designed to validate an artificial intelligence (AI)-based framework for the automated analysis of cardiac imaging data, including multi-slice cardiac computed tomography (CT) and transesophageal echocardiography (TEE). The primary objective is to predict the success of transcatheter heart valve interventions, including aortic, mitral, and tricuspid valve interventions (TAVI, TMVI, M-TEER, T-TEER). The AI framework developed in this study will rely on deep learning algorithms, particularly convolutional neural networks (CNNs) and other advanced models, to automatically segment critical anatomical structures and perform accurate measurements of these structures from CT and TEE images. These measurements will then be combined with pre-interventional clinical data to optimize patient selection and intervention planning, as well as to predict surgical outcomes with high accuracy. AI will also aim to reduce human error and inter-observer variability in the interpretation of cardiac images, which could significantly improve clinical outcomes.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DIAGNOSTIC_TEST

Medical imaging analysis via artificial intelligence algorithms

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Conditions

Heart Valve DiseaseTAVIM-TEERTTVITMVIT-TEERMitraclipTriClip

Locations

Montefiore Medical Center New York

New York, New York 10467

United States

Montreal Heart Institute, 5000 Rue Bélanger, Montréal

Montreal, Quebec H1T 1C8

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, 33404

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