Circle Method Observational Project - Non-interventional, Retrospective, Multicenter Data Collection

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut für Pharmakologie und Präventive Medizin

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

Qualifiers

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 design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed

Sponsors and collaborators