Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-02 @ 3:22 PM
Study NCT ID:
NCT05844969
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-22
First Post:
2023-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Circle Method Observational Project - Non-interventional, Retrospective, Multicenter Data Collection
Sponsor:
Institut für Pharmakologie und Präventive Medizin
Organization:
Study Overview
Official Title:
Circle Method Observational Project - Non-interventional, Retrospective, Multicenter Data Collection to Validate Circle Method for Sizing and Positioning in Bicuspid Aortic Valves
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: