Enhanced Valves Interventions and Safe AI Generated End Results (ENVISAGE)

University of Montreal

Status: Enrolling

Conditions: M-TEER; TriClip; T-TEER; TTVI; Mitraclip; TAVI; Heart Valve Disease; TMVI

Treatments: Diagnostic Test: Medical imaging analysis via artificial intelligence algorithms

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07213531

CHUBX2024/50

Details and patient eligibility

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.

Full 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.

Enrollment: 21,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

21,000 participants in 5 patient groups

TAVI

Description:

All patients who have had TAVI with a third generation transcatheter heart valve (THV). Medical imaging data (CT, TEE) and preoperative clinical data will be collected for analysis.

Treatment:

Diagnostic Test: Medical imaging analysis via artificial intelligence algorithms

TMVI

Description:

Patients who have had a TMVI with a dedicated transeptal device and screen failures. Medical imaging data (CT, TEE) and preoperative clinical data will be collected for analysis.

Treatment:

Diagnostic Test: Medical imaging analysis via artificial intelligence algorithms

TTVI

Description:

Patients who have had a TTVI with a dedicated device and screen failures. Medical imaging data (CT, TEE) and preoperative clinical data will be collected for analysis.

Treatment:

Diagnostic Test: Medical imaging analysis via artificial intelligence algorithms

M-TEER

Description:

All patients who have had a M-TEER with 1) G4 or newer iteration of MitraClip or 2) G2 or newer iteration of Pascal. Medical imaging data (CT, TEE) and preoperative clinical data will be collected for analysis.

Treatment:

Diagnostic Test: Medical imaging analysis via artificial intelligence algorithms

T-TEER

Description:

All patients who have had a T-TEER with G4 or newer iteration of TriClip or 2) G2 or newer iteration of Pascal. Medical imaging data (CT, TEE) and preoperative clinical data will be collected for analysis.

Treatment:

Diagnostic Test: Medical imaging analysis via artificial intelligence algorithms