Evaluation of ARi with OpSens SavvyWire

Terminated

• Conditions: Aortic Valve Insufficiency

• Registration Number: NCT06295068
• Lead Sponsor: Opsens, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-28
• Study Start: 2023-11-30
• Study First Submitted QC: 2024-03-05
• Study First Posted: 2024-03-06
• Primary Completion: 2024-10-17
• Study Completion: 2024-10-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of the Aortic Regurgitation Index (ARi) measured with the Opsens SavvyWire compared with regurgitation evaluation derived by Echography and Aortography	From the beginning of the procedure (first measurement is taken before the valve intervention) until to the end of the procedure (second measurement is taken after the valve Intervention), up to 2 hours

Secondary Outcome Measures

Name	Time	Method
Correlation of the Time Integration Aortic Regurgitation Index (TIARI) measured using the SavvyWire compare with regurgitation evaluation derived by Echography (TEE/TTE) and Aortography	From the beginning of the procedure (first measurement is taken before the valve intervention) until to the end of the procedure (second measurement is taken after the valve Intervention), up to 2 hours
Correlation of the Aortic Regurgitation Index Ratio measured using the Opsens SavvyWire compare with regurgitation evaluation derived by Echography and Aortography	From the beginning of the procedure (first measurement is taken before the valve intervention) until to the end of the procedure (second measurement is taken after the valve Intervention), up to 2 hours

Trial Locations

Locations (1)

AHS Morristown Medical Center; 🇺🇸 Morristown, New Jersey, United States