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

Valutazione Delle Pressioni di Riempimento Del Ventricolo Sinistro Attraverso l'Impiego di un Software di Intelligenza Artificiale Applicato Alla Stima Dello Strain Atriale Sinistro Con Ecocardiografia Speckletracking: Studio di Validazione Mediante Cateterismo Cardiaco

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05768698

Acronym

LVEDP

Enrollment

Registered

2023-03-14

Start date

2021-07-20

Completion date

2024-06-11

Last updated

2024-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Echocardiography, Heart Failure, Diastolic

Keywords

Transthoracic echocardiography, left ventricular filling pressure, artificial intelligence, right heart catheterization

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.

Interventions

DIAGNOSTIC_TESTSoftware algorithm

Validation of 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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Left ventricular filling pressure	During procedure	Invasively measured left ventricular filling pressure by right heart catheterization

Countries

United States

Contacts

Primary ContactLuigi Badano, MD, Ph.D.

l.badano@auxologico.it+390261911

Backup ContactSergio Caravita, MD, Ph.D.

s.caravita@auxologico.it+390261911

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026