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Evaluation of ARi With OpSens SavvyWire

NCT06295068 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 13

Last updated 2025-03-30

No results posted yet for this study

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.

Conditions

  • Aortic Valve Insufficiency

Interventions

DEVICE

Transcatheter Aortic Valve Replacement (TAVR)

Replacement of the aortic valve with use of the OpSens SavvyWire

DEVICE

Balloon Aortic Valvuloplasty (BAV)

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

Sponsors & Collaborators

  • Opsens, Inc.

    lead INDUSTRY

Principal Investigators

  • Philippe Généreux, Dr · AHS Morristown Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2024-10-17
Completion
2024-10-17
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06295068 on ClinicalTrials.gov