NCT06295068

Evaluation of ARi With OpSens SavvyWire

Evaluation of the Aortic Regurgitation Index (ARi) Measured With the Opsens SavvyWire to Determine the Correlation Between Regurgitation Evaluation Using Echography and Aortography

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 13 (actual)
• Sponsor: Opsens, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to establish the degree of agreement to Aortic Regurgitation (AR) severity during aortic valve intervention between the Aortic Regurgitation Index (ARi) measured by the Opsens SavvyWire, Echography and Aortography in subjects with severe aortic stenosis (AS) undergoing echo guided valve intervention. The main question it aims to answer is how the ARi measured with the Opsens SavvyWire compared with regurgitation evaluation derived by Echography and Aortography.

Conditions

• Aortic Valve Insufficiency

Interventions

Type	Name	Description
DEVICE	Transcatheter Aortic Valve Replacement (TAVR)	Replacement of the aortic valve with use of the OpSens SavvyWire
DEVICE	Balloon Aortic Valvuloplasty (BAV)	Dilation of the narrowed aortic valve by balloon inflation with use of the OpSens SavvyWire

Timeline

• Start date: 2023-11-30
• Primary completion: 2024-10-17
• Completion: 2024-10-17
• First posted: 2024-03-06
• Last updated: 2025-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study