Institute for Pharmacology and Preventive Medicine
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.
Aortic Stenosis With Bicuspid Valve
The bicuspid aortic valve (BAV) is the most common heart valve abnormality and is associated with a number of cardiac complications, including infective endocarditis, aortic dissection, aortic dilatation, and the development of severe aortic stenosis (AS). Due to its anatomical characteristics BAV has been considered a contraindication to transcatheter aortic valve implantation (TAVI), a standard treatment of AS. However, several recent trials have presented promising results indicating TAVI to be a safe alternative to surgery for low risk patients and more patients with BAV have been considered for TAVI. There are several sizing techniques for TAVI in BAV, including an annular sizing, a supra-annular sizing, and a balloon sizing, yet there is still no consensus on the most appropriate technique. Although annular sizing remains the major approach in most patients with BAV, some BAV anatomies may profit from the supra-annular sizing. Recently published consensus for sizing and positioning the balloon-expandable Edwards SAPIEN 3 transcatheter heart valve (THV) in BAV describes the anatomical features that influence sizing optimization. The novel circle technique has also been proposed in the presence of the unique anatomical factors and sizing at the supra-annular level. This method is particularly helpful for visually identifying anatomic features, indicating the sealing zone at the commissures, visually reassuring of the size and position, and treating patients with large annuli. Currently, there are limited data validating the circle method for identifying sizing and positioning for TAVI in BAV patients. In this non-interventional, retrospective, multicenter data collection and analysis we aim to validate the circle method for sizing and positioning in bicuspid aortic valves. Due to the non-interventional character of the project, no additional burden will be put on the patients eligible for inclusion.
| Study Type : | OBSERVATIONAL |
| Estimated Enrollment : | 60 participants |
| Official Title : | Circle Method Observational Project - Non-interventional, Retrospective, Multicenter Data Collection to Validate Circle Method for Sizing and Positioning in Bicuspid Aortic Valves |
| Actual Study Start Date : | 2025-06-01 |
| Estimated Primary Completion Date : | 2025-08 |
| Estimated Study Completion Date : | 2025-08 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Royal Papworth Hospital NHS Foundation Trust
Cambridge, United Kingdom, CB20AY
Not yet recruiting
Golden Jubilee National Hospital
Clydebank, United Kingdom, G814dy
Not yet recruiting
Guy's and St Thomas NHS Foundation Trust
London, United Kingdom, C17
Not yet recruiting
University Hospitals Sussex NHS Foundation Trust
Worthing, United Kingdom, BN112DH