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Evaluation of ARi With OpSens SavvyWire

Terminated · NCT06295068

Conditions: Aortic Valve Insufficiency

At a glance

Research payments reported, 2025
$19,500
U.S. investigators named
1
Sites paid
1
Planned or actual enrollment
13

About the trial

Sponsor
Opsens, Inc.
Tested
Transcatheter Aortic Valve Replacement (TAVR) (device), Balloon Aortic Valvuloplasty (BAV) (device)
Dates
Started 2023-11-30; completion 2024-10-17
Results posted
Not yet

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.

From ClinicalTrials.gov, last updated 2025-03-30. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Cardiva Medical, Inc. reported $19,500 in research payments for this study in 2025 (2 payments).

Products named: Savvywire

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.