Evaluation of ARi with OpSens SavvyWire

OpSens

Status: Terminated

Conditions: Aortic Valve Insufficiency

Treatments: Device: Transcatheter Aortic Valve Replacement (TAVR); Device: Balloon Aortic Valvuloplasty (BAV)

Study type: Observational

Funder types: Industry

Identifiers

NCT06295068

PRT-1400-11

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.