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The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration (POPular PET TAVI)

NCT05758662 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2026-05-19

No results posted yet for this study

Summary

A multicentre cross-sectional cohort study to assess the difference in bioprosthetic micro-calcification activity, detected with 18F-NaF PET-CT, as early marker of transcatheter valve degeneration, between patients with vs. without subclinical leaflet thrombosis at five years after TAVI; and between patients with intra-annular vs. supra-annular TAVI prostheses.

Conditions

  • Aortic Valve Stenosis

Interventions

DIAGNOSTIC_TEST

18F-sodium fluoride Positron Emission Tomography (18F-NaF PET), Cardiac Computed Tomography (CT), Transthoracic Echocardiography (TTE)

Patients undergo a hybrid 18F-NaF-PET CT scan and TTE at five years after TAVI

Sponsors & Collaborators

  • St. Antonius Research Fund

    collaborator UNKNOWN

  • Medtronic

    collaborator INDUSTRY

  • St. Antonius Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-16
Primary Completion
2026-10-01
Completion
2026-10-01

Countries

  • Denmark
  • Netherlands
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05758662 on ClinicalTrials.gov