NCT05758662

Brief 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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
3 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

November 16, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

1.6 years

First QC Date

February 15, 2023

Last Update Submit

April 8, 2024

Conditions

Aortic Valve Stenosis

Keywords

TAVITAVRSubclinical Leaflet ThrombosisBioprosthetic Valve DeteriorationIntra-annularSupra-annular

Outcome Measures

Primary Outcomes (3)

  • Quantified bioprosthetic micro-calcification activity

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

    5 years after TAVI

  • Subclinical Leaflet Thrombosis

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

    5 years after TAVI

  • Valve dysfunction

    Transvalvular gradients assessed with transthoracic echocardiography

    5 years after TAVI

Study Arms (2)

Intra-annular

Patients with an intra-annular Sapien TAVI prosthesis

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

Supra-annular

Patients with a supra-annular CoreValve Evolut TAVI prosthesis

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

Interventions

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

Intra-annularSupra-annular

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent TAVI about five years ago will be consecutively screened for eligibility from the ongoing, prospective, TAVI registries of the participating study sites and will be asked to undergo hybrid PET-CT imaging and transthoracic echocardiography.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Rigshospitalet

Copenhagen, Denmark

RECRUITING

St. Antonius Hospital

Nieuwegein, Utrecht, 3435 CM, Netherlands

RECRUITING

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

University of Edinburgh

Edinburgh, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Central Study Contacts

Dirk-Jan van Ginkel, MD

CONTACT

+31 (0)88 320 66 48d.van.ginkel@antoniusziekenhuis.nl

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

CONTACT

jurtenberg@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, MSc

Study Record Dates

First Submitted

February 15, 2023

First Posted

March 7, 2023

Study Start

November 16, 2023

Primary Completion

July 1, 2025

Study Completion

November 1, 2025

Last Updated

April 10, 2024

Record last verified: 2024-04

Locations

GB(1)NL(2)DK(1)