Assessment of Left Ventricular Filling Pressure by Applying Artificial Intelligence Algorithms to Left Atrial Speckle-tracking Echocardiography

Recruiting

• Conditions: Heart Failure, Diastolic; Echocardiography

• Registration Number: NCT05768698
• Lead Sponsor: Istituto Auxologico Italiano

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-20
• Study First Submitted: 2023-02-22
• Study First Submitted QC: 2023-03-03
• Study First Posted: 2023-03-14
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-16
• Primary Completion: 2024-06-11
• Study Completion: 2024-06-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• ≥ 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),

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Left ventricular filling pressure	During procedure	Invasively measured left ventricular filling pressure by right heart catheterization

Trial Locations

Locations (1)

Philips Healthcare; 🇺🇸 Andover, Massachusetts, United States