The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration (POPular PET TAVI)
- Conditions
- Aortic Valve Stenosis
- Interventions
- Diagnostic Test: 18F-sodium fluoride Positron Emission Tomography (18F-NaF PET), Cardiac Computed Tomography (CT), Transthoracic Echocardiography (TTE)
- Registration Number
- NCT05758662
- Lead Sponsor
- St. Antonius Hospital
- 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.
- Detailed 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 & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
- 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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Intra-annular 18F-sodium fluoride Positron Emission Tomography (18F-NaF PET), Cardiac Computed Tomography (CT), Transthoracic Echocardiography (TTE) Patients with an intra-annular Sapien TAVI prosthesis Supra-annular 18F-sodium fluoride Positron Emission Tomography (18F-NaF PET), Cardiac Computed Tomography (CT), Transthoracic Echocardiography (TTE) Patients with a supra-annular CoreValve Evolut TAVI prosthesis
- Primary Outcome Measures
Name Time Method Subclinical Leaflet Thrombosis 5 years after TAVI Hypo Attenuated Leaflet Thickening (HALT) assessed with cardiac Computed Tomography
Quantified bioprosthetic micro-calcification activity 5 years after TAVI 18F-NaF uptake originating from any of the bioprosthetic valve leaflets assessed with 18F-NaF Positron Emission Tomography
Valve dysfunction 5 years after TAVI Transvalvular gradients assessed with transthoracic echocardiography
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Amsterdam UMC
🇳🇱Amsterdam, Netherlands
St. Antonius Hospital
🇳🇱Nieuwegein, Utrecht, Netherlands
Rigshospitalet
🇩🇰Copenhagen, Denmark
University of Edinburgh
🇬🇧Edinburgh, United Kingdom