CompletedNo phase
Circle Method Observational Project - Non-interventional, Retrospective, Multicenter Data Collection
Key facts
- Who runs it
- Institut für Pharmakologie und Präventive Medizin
- Where
- United Kingdom4 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 140 people enrolled
- Started
- 6 Jun 2025
- Ended
- 1 Jun 2026
- Type of study
- Observational
- Record updated
- 3 August 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Patients with bicuspid aortic valves who underwent aortic valve replacement with a balloon expandable valve (SAPIEN 3 / Ultra)
- Computed Tomography data available
Who cannot take part
- none
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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).
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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.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Circle Method Observational Project - Non-interventional, Retrospective, Multicenter Data Collection to Validate Circle Method for Sizing and Positioning in Bicuspid Aortic Valves
- Record updated
- 3 August 2026