Aortic Valve Stenosis, Heart Valve Diseases
Conditions
Brief summary
A single-center prospective interventional trial. Patients implanted with a sutureless bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden from 2012 will be eligible. 4-dimensional volume-rendered computed tomography (CT) of the heart will be performed. The aim of the CT is to assess valve geometry and hypo-atrenuated leaflet thickening. Results of the CT examination, preoperative clinical characteristics, and postoperative clinical data will be registered. Data will be collected prospectively and retrospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.
Interventions
Sponsors
Karolinska Institutet
Karolinska University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Implanted with a sutureless Perceval (LivaNova) sutureless bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden between 2012 and 2016 * Provide written informed consent
Exclusion criteria
•Contraindication for CT with intravenous contrast injection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Regional expansion of valve prosthesis | At CT performed once no less than 30 days and up to 10 years after aortic valve replacement | Regional expansion measured using the angle formed by the border of each prosthetic leaflet and the centre point of the valve |
| Overall expansion of valve prosthesis | At CT performed once no less than 30 days and up to 10 years after aortic valve replacement | Overall expansion of the implanted prosthesis calculated as the ratio between the ex vivo cross-sectional area and the in vitro cross-sectional area of the implanted valve |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eccentricity of valve prosthesis | At CT performed once no less than 30 days and up to 10 years after aortic valve replacement | Eccentricity of the implanted prosthesis calculated as (\[max diameter-min diameter\]/max diameter)×100 |
Countries
Sweden
Outcome results
None listed