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NOT YET RECRUITING
NCT05844969

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

Sponsor: Institut für Pharmakologie und Präventive Medizin

View on ClinicalTrials.gov

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

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