Primary objectives: 1. To assess the difference in bioprosthetic leaflet 18F-NaF PET activity, as an early marker of transcatheter valve degeneration, between patients with vs. without SCLT at five years after TAVI.2. To assess the difference in…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quantified bioprosthetic micro-calcification activity (18F-NaF uptake)
Subclinical leaflet thrombosis (Hypo Attenuating Leaflet Thickening and Reduced
Leaflet Motion)
Bioprosthetic valve dysfunction
Secondary outcome
Demographics, comorbidities, cardiovascular risk factors and scores, clinical
status and frailty scales, laboratory values, procedural factors, and baseline
and (early) follow-up echocardiography measurements.
Background summary
Subclinical leaflet thrombosis (SCLT) occurs frequently after transcatheter
aortic valve implantation (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
clinical 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 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.
Study objective
Primary objectives:
1. To assess the difference in bioprosthetic leaflet 18F-NaF PET activity, as
an early marker of transcatheter valve degeneration, between patients with vs.
without SCLT at five years after TAVI.
2. To assess the difference in quantified bioprosthetic leaflet 18F-NaF PET
activity between patients with intra-annular vs. supra-annular TAVI prostheses
at five years after TAVI.
Secondary objectives:
1. To assess the prevalence of SCLT at five years after TAVI.
2. To assess whether SCLT and bioprosthetic leaflet 18F-NaF PET activity are
associated with echocardiographic measures of valve dysfunction.
Study design
International, cross-sectional cohort study.
Study burden and risks
Patient burdening consists of one study visit to the hospital, during which a
PET-CT scan and a transthoracic echocardiogram will be made.
Risk consists of a radiation dose of 8 mSv with the PET-CT scan. Given their
age (>75 years), this will not significantly affect their lifetime risk of
cancer.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
o Successful TAVI with Sapien or CoreValve Evolut prosthesis about five years
ago
o Able to undergo hybrid 18F-NaF PET-CT scan and transthoracic echocardiography
o Written informed consent
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
o Temporary or chronic oral anticoagulation use after TAVI
o Known severe renal insufficiency
o History of iodine contrast allergy
o Known severe paravalvular regurgitation
o History of valve-in-valve procedure
o History of aortic valve re-intervention (including percutaneous paravalvular
leak closure)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05758662 |
| CCMO | NL82791.100.23 |