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

Sponsor
Istituto Auxologico Italiano (Other)
Overall Status
Recruiting
CT.gov ID
NCT05768698
Collaborator
Philips Healthcare (Industry)
20
Enrollment
1
Location
22.7
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Software algorithm

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Jul 20, 2021
Anticipated Primary Completion Date :
Jun 11, 2023
Anticipated Study Completion Date :
Jun 11, 2023

Outcome Measures

Primary Outcome Measures

  1. Left ventricular filling pressure [During procedure]

    Invasively measured left ventricular filling pressure by right heart catheterization

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Philips Healthcare Andover Massachusetts United States 01810

Sponsors and Collaborators

  • Istituto Auxologico Italiano
  • Philips Healthcare

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Istituto Auxologico Italiano
ClinicalTrials.gov Identifier:
NCT05768698
Other Study ID Numbers:
  • 09V102
First Posted:
Mar 14, 2023
Last Update Posted:
Mar 14, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Istituto Auxologico Italiano
Transthoracic echocardiography
left ventricular filling pressure
artificial intelligence
right heart catheterization
Additional relevant MeSH terms:
Heart Failure, Diastolic

Study Results

No Results Posted as of Mar 14, 2023