PROSPECTIVE EVALUATION OF HEARTFOCUS
Cardiac Disease
Bottom Line
View on ClinicalTrials.gov: NCT05874128 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Using HeartFocus software with AI guidance (Novices) (Device); Using HeartFocus software without AI-guidance (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- DESKi
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Left Ventricular Size (Qualitative Visual Assessment) |
100; 100 | — |
| PRIMARY The Left Ventricular Function (Qualitative Visual Assessment) |
100; 100 | — |
| PRIMARY The Right Ventricle Size (Qualitative Visual Assessment) |
100; 100 | — |
| PRIMARY The Presence of Non-trivial Pericardial Effusion (Qualitative Visual Assessment) |
100; 100 | — |
| SECONDARY The Function of the Right Ventricle (Qualitative Visual Assessment) |
99.6; 100 | — |
| SECONDARY The Left Atrium Size (Qualitative Visual Assessment) |
100; 100 | — |
| SECONDARY The Right Atrium Size (Qualitative Visual Assessment) |
98.8; 100 | — |
| SECONDARY The Segmental Kinetics of the Left Ventricle (Qualitative Visual Assessment) |
95.4; 100 | — |
| SECONDARY The Aortic Valve (Qualitative Visual Assessment) |
98.8; 100 | — |
| SECONDARY The Mitral Valve (Qualitative Visual Assessment) |
100; 100 | — |
| SECONDARY The Tricuspid Valve (Qualitative Visual Assessment) |
95.4; 99.2 | — |
| SECONDARY The Size of Inferior Vena Cava (Qualitative Visual Assessment) |
78.3; 98.3 | — |
| SECONDARY Apical-2-Chamber (Diagnostic Quality Clip) |
82.5; 98.3 | — |
| SECONDARY Apical-3-Chamber (Diagnostic Quality Clip) |
90; 100 | — |
| SECONDARY Apical-4-Chamber (Diagnostic Quality Clip) |
96.2; 100 | — |
| SECONDARY Apical-5-Chamber (Diagnostic Quality Clip) |
93.3; 99.2 | — |
| SECONDARY Parasternal Long Axis (Diagnostic Quality Clip) |
97.5; 100 | — |
| SECONDARY Parasternal Short Axis Aortic (Diagnostic Quality Clip) |
89.2; 99.2 | — |
| SECONDARY Parasternal Short Axis Mitral (Diagnostic Quality Clip) |
90.8; 99.6 | — |
| SECONDARY Parasternal Short Axis Papillary Muscles (Diagnostic Quality Clip) |
97.1; 99.2 | — |
| SECONDARY Sub Costal-4-Chamber (Diagnostic Quality Clip) |
89.2; 98.3 | — |
| SECONDARY Sub Costal Inferior Vena Cava (Diagnostic Quality Clip) |
77.5; 98.3 | — |
Summary
Eligibility Criteria
Inclusion Criteria
Patient (male or female) over 18 years old, Patient having an echocardiography examination scheduled in one of the two investigation centers.
Patient who has given his non-objection to participate in the research
Exclusion Criteria
Patient subject to a measure of legal protection (safeguard of justice, guardianship or curatorship), Patient deprived of liberty by judicial or administrative decision, Patient being unable to give his non-objection, Pregnant or breastfeeding women, Patient with cardiac anatomy that does not allow reference electrocardiographic sections to be made (situs inversus, single ventricle, congenital anomalies, etc), Patient having benefited from prior echocardiographic exams whose reports mention poor or weak echogenicity, Patient having known chest deformity that has already been mentioned in previous reports or has been the subject of investigations (pectum excavatum), Patient who has undergone total or partial pneumectomy
Data sourced from ClinicalTrials.gov (NCT05874128). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.