About this trial
The goal of this non-interventional, retrospective data analysis is to validate the circle method for patients with bicuspid aortic heart valves undergoing transcatheter aortic heart valve implantation (TAVI).
The main aims are:
* to assess whether patients with bicuspid aortic valves that received a TAVI suffered from fewer complications
* if valve size was identical to the one determined using the circle method compared to * a case where circle method derived valve size is different from the actually implanted valve * to develop recommendations on how to size the valve using the circle method.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with bicuspid aortic valves who underwent aortic valve replacement with a balloon expandable valve (SAPIEN 3 / Ultra)
Computed Tomography data available
Disqualifiers
None
Trial population
Adult patients with bicuspid valve disease who underwent aortic valve replacement.
Trial design
Case-only
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Complications
To assess whether patients with bicuspid aortic valves that received a SAPIEN 3 / Ultra THV suffered from fewer complications * if valve size was identical to the one determined using the circle method compared to * a case where circle method derived valve size is different from the actually implanted valve
Secondary outcomes
Sizing with Circle Method
To develop recommendations on how to size the valve using the circle method.
Sponsors and contacts
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Institut für Pharmakologie und Präventive Medizin
Lead sponsor
Edwards Lifesciences
Collaborator
This trial is not recruiting at the moment. You can still explore other options: