Evaluation of ARi With OpSens SavvyWire

Opsens, Inc.13 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Aortic Valve Insufficiency

Interventions

Transcatheter Aortic Valve Replacement (TAVR)DEVICE

Replacement of the aortic valve with use of the OpSens SavvyWire

Balloon Aortic Valvuloplasty (BAV)DEVICE

Dilation of the narrowed aortic valve by balloon inflation with use of the OpSens SavvyWire

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

AHS Morristown Medical Center

Morristown, New Jersey, United States

Outcomes

Primary Outcomes

Correlation of the Aortic Regurgitation Index (ARi) measured with the Opsens SavvyWire compared with regurgitation evaluation derived by Echography and Aortography

Time frame: 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 Outcomes

Correlation of the Time Integration Aortic Regurgitation Index (TIARI) measured using the SavvyWire compare with regurgitation evaluation derived by Echography (TEE/TTE) and Aortography

Correlation of the Aortic Regurgitation Index Ratio measured using the Opsens SavvyWire compare with regurgitation evaluation derived by Echography and Aortography

Data from ClinicalTrials.gov

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