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

Launched by INSTITUT FÜR PHARMAKOLOGIE UND PRÄVENTIVE MEDIZIN · Apr 25, 2023

Keywords

ClinConnect Summary

The Circle Method Observational Project is a study looking at patients with a specific heart condition called aortic stenosis, particularly those who have a bicuspid aortic valve. This is a type of heart valve that can lead to problems, and the study aims to understand how well a new method, called the circle method, helps determine the right size of replacement heart valve for these patients during a procedure known as transcatheter aortic valve implantation (TAVI). The researchers want to find out if using this method leads to fewer complications and if the valve size they choose matches the actual valve that is implanted.

To participate in this study, patients must be between 65 and 74 years old and have had aortic valve replacement with a specific type of balloon-expandable valve called SAPIEN 3 or Ultra. Additionally, they need to have certain imaging data available to help with the analysis. This trial is still in the planning stage and has not yet started recruiting participants. Overall, the goal is to improve how doctors size these heart valves, which could lead to better outcomes for patients undergoing this important procedure.

Gender

ALL

Eligibility criteria

• 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