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

Heart Failure, Diastolic Clinical Trial

— LVEDP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05768698
• Other study ID #: 09V102
• Status: Recruiting
• Start date: July 20, 2021
• Est. completion date: June 11, 2024

Study information

• Verified date: April 2024
• Source: Istituto Auxologico Italiano
• Contact: Luigi Badano, MD, Ph.D.
• Phone: +390261911
• Email: l.badano[@]auxologico.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 11, 2024
• Est. primary completion date: June 11, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Echocardiography
• Heart Failure, Diastolic

Intervention

Diagnostic Test:
• Software 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

Locations

Country	Name	City	State
United States	Philips Healthcare	Andover	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano	Philips Healthcare

Country where clinical trial is conducted

United States, 

Outcome

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