Assessment of Left Ventricular Filling Pressure by Applying Artificial Intelligence Algorithms to Left Atrial Speckle-tracking Echocardiography
Status unconfirmed
Conditions studied: Heart Failure, Diastolic, Echocardiography
In brief
The goal of this single-center, prospective, observational study is to validate a software package based on an artificial intelligence algorithm for automated non-invasive estimation of LVFP against invasively measured ones by left and right heart catheterization; In addition, the added value of this new automated software to detect increased LVEDP \> 15 mm Hg compared to the current ASE/EACVI algorithm for assessing diastolic dysfunction and longitudinal left atrial strain during the reservoir phase will be evaluated.
Key facts
- Study ID
- NCT05768698
- Run by
- Istituto Auxologico Italiano
- People needed
- 20
- Starts
- 2021-07-20
- Expected to finish
- 2024-06-11
- Last updated by the study team
- 2024-04-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥ 18 yo,
- Signed informed consent to be part of this study,
- No pregnancy,
- Good acoustic window and patient cooperation to obtain good 2- and 3-dimensional datasets focused on left atrium (LA),
You may not qualify if…
- Unwillingness to be part of the study,
- Patients with poor 2-dimensional imaging quality in ≥ 1 LA segment or lacking of a discernible R-R interval, which might preclude accurate strain measurements,
- Patients with more than mild mitral valve heart disease, aortic regurgitation, left side valvular prosthesis or mitral valve repair, mitral annulus calcification (≥ 5 mm),
- Patients with history or presence of atrial fibrillation (AF), supraventricular arrhythmias, ventricular paced rhythm, left bundle branch block (LBBB),
- Patients taking diuretics or vasodilators (nitrates) on the day of the examination, which could alter loading conditions.
Where it is running
- Philips Healthcare — Andover, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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