Evaluation of ARi With OpSens SavvyWire

Aortic Valve Insufficiency Clinical Trial

— ARi  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06295068
• Other study ID #: PRT-1400-11
• Status: Recruiting
• Start date: November 30, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: March 2024
• Source: Opsens, Inc.
• Contact: Samuel Magnan, B.Sc.
• Phone: (418) 781-0333
• Email: clinical[@]opsens.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Insufficiency

Intervention

Device:
• Transcatheter Aortic Valve Replacement (TAVR)
Replacement of the aortic valve with use of the OpSens SavvyWire
• Balloon Aortic Valvuloplasty (BAV)
Dilation of the narrowed aortic valve by balloon inflation with use of the OpSens SavvyWire

Locations

Country	Name	City	State
United States	AHS Morristown Medical Center	Morristown	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Opsens, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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