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NCT Number: NCT05758662

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet, Copenhagen, Denmark

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About this study

Subclinical leaflet thrombosis (SCLT) occurs frequently after TAVI and has been associated with an increased risk of valve dysfunction. A persistent form of SCLT may lead to thrombus calcification and valve degeneration and increase the long-term risk of symptomatic bioprosthetic valve deterioration. Intra-annular in comparison to supra-annular TAVI valves have been associated with a higher risk of SCLT and valve thrombosis. Intra-annular valves may create larger neo-sinuses and flow stagnation zones, which favour local thrombogenicity. Whether different prosthesis types lead to a higher degree of transcatheter valve calcification and degeneration is currently unexplored. Recently, 18F-sodium fluoride (18F-NaF) positron emission tomography (PET) has emerged as a non-invasive modality capable of imaging bioprosthetic micro-calcification activity, which is an early and powerful predictor of valvular dysfunction and eventually valve failure. In the present study, we investigate for the first time, the differences in quantified bioprosthetic micro-calcification activity with 18F-NaF PET as early marker of transcatheter valve degeneration between patients with and without SCLT and between patients with intra-annular vs. supra-annular prostheses at five years after TAVI.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Successful TAVI with Sapien or CoreValve Evolut prosthesis about 5 years ago
  • Able to undergo hybrid 18F-NaF PET-CT imaging and transthoracic echocardiography
  • Written informed consent

Exclusion criteria

  • Temporary or chronic oral anticoagulation use after TAVI
  • Known severe renal insufficiency
  • Known severe paravalvular regurgitation
  • History of valve-in-valve procedure
  • History of aortic valve re-intervention (including percutaneous paravalvular leak closure)

Treatment and study plan

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

Diagnostic Test

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

Primary outcomes

  1. Quantified bioprosthetic micro-calcification activity

    Time frame: 5 years after TAVI

    18F-NaF uptake originating from any of the bioprosthetic valve leaflets assessed with 18F-NaF Positron Emission Tomography

  2. Subclinical Leaflet Thrombosis

    Time frame: 5 years after TAVI

    Hypo Attenuated Leaflet Thickening (HALT) assessed with cardiac Computed Tomography

  3. Valve dysfunction

    Time frame: 5 years after TAVI

    Transvalvular gradients assessed with transthoracic echocardiography

Study contacts

Contact information is provided by the study sponsor or research team.

Dirk-Jan van Ginkel, MD

CONTACT

[email protected]

+31 (0)88 320 66 48

Prof. J.M. ten Berg, MD, PhD, MSc

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Collaborators

  • Medtronic
  • St. Antonius Research Fund

Registry information

Official study title

The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 7, 2023
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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