Aortic Valve Insufficiency
Conditions
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.
Interventions
DEVICETranscatheter Aortic Valve Replacement (TAVR)
Replacement of the aortic valve with use of the OpSens SavvyWire
DEVICEBalloon Aortic Valvuloplasty (BAV)
Dilation of the narrowed aortic valve by balloon inflation with use of the OpSens SavvyWire
Sponsors
Opsens, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed