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

Aortic Valve Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05758662
• Other study ID #: NL82791.100.23
• Status: Recruiting
• Start date: November 16, 2023
• Est. completion date: November 2025

Study information

• Verified date: April 2024
• Source: St. Antonius Hospital
• Contact: Dirk-Jan van Ginkel, MD
• Phone: +31 (0)88 320 66 48
• Email: d.van.ginkel[@]antoniusziekenhuis.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: November 2025
• Est. primary completion date: July 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Thrombosis

Intervention

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

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen
Netherlands	Amsterdam UMC	Amsterdam
Netherlands	St. Antonius Hospital	Nieuwegein	Utrecht
United Kingdom	University of Edinburgh	Edinburgh

Sponsors (3)

Lead Sponsor	Collaborator
St. Antonius Hospital	Medtronic, St. Antonius Research Fund

Countries where clinical trial is conducted

Denmark,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Subclinical Leaflet Thrombosis	Hypo Attenuated Leaflet Thickening (HALT) assessed with cardiac Computed Tomography	5 years after TAVI
Primary	Valve dysfunction	Transvalvular gradients assessed with transthoracic echocardiography	5 years after TAVI