Evaluation of ARi With OpSens SavvyWire

Stopped early

Conditions studied: Aortic Valve Insufficiency

In brief

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.

Key facts

Study ID

NCT06295068

Run by

Opsens, Inc.

People needed

13

Starts

2023-11-30

Expected to finish

2024-10-17

Last updated by the study team

2025-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients undergoing TAVR suitable for intraoperative acquisition of TEE/TTE
• Age > 18 years
• Able and willing to give informed consent.

You may not qualify if…

• Hemodynamic instability making use of additional hemodynamic measurement inappropriate or 24-hour survival unlikely
• Subject is considered part of a vulnerable population.

Where it is running

• AHS Morristown Medical Center — Morristown, New Jersey, United States

Full record on ClinicalTrials.gov

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