NCT07213531 Enhanced Valves Interventions and Safe AI Generated End Results
| NCT ID | NCT07213531 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Montreal Heart Institute |
| Condition | Heart Valve Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 21,000 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 21,000 participants in total. It began in 2024-05-01 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Thomas Modine, MD, PhD
PRINCIPAL INVESTIGATOR
University Hospital Bordeaux, France
Frequently Asked Questions
Who can join the NCT07213531 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Valve Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07213531 currently recruiting?
Yes, NCT07213531 is actively recruiting participants. Contact the research team at thomasmodine@gmail.com for enrollment information.
Where is the NCT07213531 trial being conducted?
This trial is being conducted at New York, United States, Montreal, Canada, Toronto, Canada, Vancouver, Canada and 11 additional locations.
Who is sponsoring the NCT07213531 clinical trial?
NCT07213531 is sponsored by Montreal Heart Institute. The principal investigator is Thomas Modine, MD, PhD at University Hospital Bordeaux, France. The trial plans to enroll 21,000 participants.