Circle Method Observational Project - Non-interventional, Retrospective, Multicenter Data Collection
1 other identifier
observational
140
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2025
Shorter than P25 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2023
CompletedFirst Posted
Study publicly available on registry
May 6, 2023
CompletedStudy Start
First participant enrolled
June 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
CompletedAugust 3, 2026
April 1, 2025
12 months
April 25, 2023
July 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Complications
To assess whether patients with bicuspid aortic valves that received a SAPIEN 3 / Ultra THV 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
12 months
Secondary Outcomes (1)
Sizing with Circle Method
12 months
Eligibility Criteria
Adult patients with bicuspid valve disease who underwent aortic valve replacement.
You may qualify if:
- Patients with bicuspid aortic valves who underwent aortic valve replacement with a balloon expandable valve (SAPIEN 3 / Ultra)
- Computed Tomography data available
You may not qualify if:
- \- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
The Essex Cardiothoracic Centre
Basildon, England, SS16 5NL, United Kingdom
Royal Papworth Hospital NHS Foundation Trust
Cambridge, CB20AY, United Kingdom
Guy's and St Thomas NHS Foundation Trust
London, SE17EH, United Kingdom
University Hospitals Sussex NHS Foundation Trust
Worthing, BN112DH, United Kingdom
Study Officials
- STUDY DIRECTOR
Pierluigi Costanzo, Dr.
Royal Papworth Hospital NHS Foundation Trust
- PRINCIPAL INVESTIGATOR
Ioannis Lianos, Dr.
Guy's and St Thomas NHS Foundation Trust
- PRINCIPAL INVESTIGATOR
Tiffany Patterson, Dr.
Guy's and St Thomas NHS Foundation Trust
- PRINCIPAL INVESTIGATOR
Timothy Bagnall, Dr.
University Hospitals Sussex NHS Foundaton Trust
- PRINCIPAL INVESTIGATOR
Christopher Cook, Dr.
Essex Cardiothoracic Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Target Duration
- 12 Months
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2023
First Posted
May 6, 2023
Study Start
June 6, 2025
Primary Completion
June 1, 2026
Study Completion
June 1, 2026
Last Updated
August 3, 2026
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share
Only anonymized, aggregated data will be shared.