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

Aortic Stenosis With Bicuspid Valve Clinical Trial

Official title:

Circle Method Observational Project - Non-interventional, Retrospective, Multicenter International Data Collection to Validate Circle Method for Sizing and Positioning in Bicuspid Aortic Valves

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05844969
• Other study ID #: CMOP
• Status: Recruiting
• Start date: July 17, 2023
• Est. completion date: December 2023

Study information

• Verified date: September 2023
• Source: Institut für Pharmakologie und Präventive Medizin
• Contact: Marie F Zielinski
• Phone: +49 4471 850 3326
• Email: marie.zielinski[@]ippmed.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 international 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with bicuspid aortic valves who underwent aortic valve replacement with a balloon expandable valve (SAPIEN 3 / Ultra)

• Computed Tomography data available

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Aortic Stenosis With Bicuspid Valve
• Aortic Valve Stenosis
• Bicuspid Aortic Valve Disease

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Padova	Padova

Sponsors (2)

Lead Sponsor	Collaborator
Institut für Pharmakologie und Präventive Medizin	Edwards Lifesciences

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sizing with Circle Method	To develop recommendations on how to size the valve using the circle method.	12 months