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Circle Method Observational Project - Non-interventional, Retrospective, Multicenter Data Collection
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.
Official title: Circle Method Observational Project - Non-interventional, Retrospective, Multicenter Data Collection to Validate Circle Method for Sizing and Positioning in Bicuspid Aortic Valves
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
60
Start Date
2025-06-01
Completion Date
2025-08
Last Updated
2025-04-22
Healthy Volunteers
No
Conditions
Locations (4)
Royal Papworth Hospital NHS Foundation Trust
Cambridge, United Kingdom
Golden Jubilee National Hospital
Clydebank, United Kingdom
Guy's and St Thomas NHS Foundation Trust
London, United Kingdom
University Hospitals Sussex NHS Foundation Trust
Worthing, United Kingdom