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Clinical Trials in Italy / NCT07213531
Recruiting Observational

Enhanced Valves Interventions and Safe AI Generated End Results

NCT07213531 · tracked via the Priya Life Science Italy tracker
Sponsor
Montreal Heart Institute
Phase
Observational
Started
2024-05-01
Last updated
2025-10-09

Condition(s) studied

Heart Valve DiseaseTAVIM-TEERTTVITMVIT-TEERMitraclipTriClip

Investigational drug(s) / intervention(s)

Medical imaging analysis via artificial intelligence algorithms

Medical 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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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.

Trial sites (15)

FacilityCityRegionStatus
Montefiore Medical Center New York New York New York Recruiting
Montreal Heart Institute, 5000 Rue Bélanger, Montréal Montreal Quebec Recruiting
St Michael's Hospital Toronto Toronto Canada Recruiting
St Paul's Hospital Vancouver Vancouver Canada Recruiting
Centre Hospitalier Universitaire (CHU) de Bordeaux, 12 rue Dubernat 33404 Talence cedex Bourdeaux France Recruiting
CHU Lille Lille France Recruiting
CHU Marseille Marseille France Recruiting
Centre Cardiologique du Nord Paris Paris France Recruiting
Institut Cardiovasculaire Paris-Sud Paris Paris France Recruiting
Centre Hospitalier Universitaire Rennes Rennes France Recruiting
Clinque Pasteur Toulouse - France Toulouse France Recruiting
University Medical Center Hamburg-Eppendorf Hamburg Germany Recruiting
Heart Valve Center Mainz Mainz Germany Recruiting
Istituto Clinico Città di Brescia Brescia Italy Recruiting
San Raffaele Heart Valve Center Milan Milan Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07213531 on ClinicalTrials.gov ↗ ← All trials in Italy