Leaflet Thickening and Stent Geometry in Sutureless Bioprosthetic Aortic Valves
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Regional expansion of valve prosthesis
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Cardiac CT imaging
Intervention: 4-dimensional volume-rendered computed tomography (Radiation)
Outcomes
Primary Outcomes
Regional expansion of valve prosthesis
Time Frame: 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
Time Frame: 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 Outcomes
- Eccentricity of valve prosthesis(At CT performed once no less than 30 days and up to 10 years after aortic valve replacement)
Investigators
Magnus Dalén
MD PhD
Karolinska University Hospital