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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05768698
Other study ID # 09V102
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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
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