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

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Enrollment: 140

Sponsor: Institut für Pharmakologie und Präventive Medizin

Summary

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

Inclusion Criteria: * Patients with bicuspid aortic valves who underwent aortic valve replacement with a balloon expandable valve (SAPIEN 3 / Ultra) * Computed Tomography data available Exclusion Criteria: \- none

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05844969). StuddyBuddy aggregates publicly available trial information.