Evaluation of ARi With OpSens SavvyWire

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-30

Study Completion Date

2024-10-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Aortic Valve Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Transcatheter Aortic Valve Replacement (TAVR)

Replacement of the aortic valve with use of the OpSens SavvyWire

Intervention Type DEVICE

Balloon Aortic Valvuloplasty (BAV)

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No