aortic valve stenosis narrowing of the aortic valve
Conditions
Interventions
N.v.t.
Sponsors
St. Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Secondary
| Measure | Time frame |
|---|---|
| Demographics, comorbidities, cardiovascular risk factors and scores, clinical status and frailty scales, laboratory values, procedural factors, and baseline and (early) follow-up echocardiography measurements. | — |
Primary
| Measure | Time frame |
|---|---|
| Quantified bioprosthetic micro-calcification activity (18F-NaF uptake) Subclinical leaflet thrombosis (Hypo Attenuating Leaflet Thickening and Reduced Leaflet Motion) Bioprosthetic valve dysfunction | — |
Countries
Denmark, Netherlands, United Kingdom
Contacts
Public ContactD.J. Ginkel
St. Antonius Ziekenhuis
Outcome results
None listed