Clinical Trial

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

Completed
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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.
Protocol Amendment History 4 changes
critical Completed without a posted recruiting period 2026-07-31
notable Enrollment increased: 60 -> 140 participants 2026-07-31
notable Primary completion pushed: 2025-08 -> 2026-06-01 2026-07-31
minor Completion pushed: 2025-08 -> 2026-06-01 2026-07-31
Trial Details
NCT Number NCT05844969
Lead Sponsor Institut für Pharmakologie und Präventive Medizin
Collaborators: Edwards Lifesciences
Conditions Aortic Stenosis With Bicuspid Valve
Enrollment 140 participants
Start Date 2025-06-06
Primary Completion 2026-06-01 (estimated)
Study Completion 2026-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-03