An interventional study of AI-assisted point-of-care ultrasound (POCUS) in Heart Failure, sponsored by University of Alberta. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by University of Alberta · Not applicable, Interventional, and Diagnostic
This is a prospective, multicenter, cluster randomised trial which will assess the feasibility and acceptability of AI-assisted point of care echocardiography on HF detection and downstream care processes for patients with suspected HF discharged from the Emergency Department.
Heart failure remains underdiagnosed in frontline care settings, in part due to limited access to timely echocardiography. Recent advances in artificial intelligence (AI)-assisted echocardiography may facilitate scalable bedside screening through automated image acquisition support and interpretation.
This is a prospective, multicenter, cluster randomised trial which will assess the feasibility and acceptability of routine implementation of AI-assisted point of care echocardiography on HF detection and downstream processes of care for patients with suspected HF being discharged from the Emergency Department.
This study will be carried out at 2 participating Emergency Departments (EDs) in Alberta, Canada. Each ED site will alternate monthly between Intervention (AI-assisted echocardiography) and Control (Usual Care) periods.
During intervention periods, patients with suspected HF will undergo AI-assisted echocardiography using a handheld point of care EchoNous Kosmos device by the treating ED physician. The US2.ai algorithm will generate an AI-automated echo report. During control periods, patients will be managed according to usual care.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 84 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University of Alberta is the lead sponsor of 823 studies on the registry; 169 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
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elevated natriuretic peptides (NT-proBNP>125pg/mL or BNP>50pg/mL); drawn as part of standard of care of evaluation in the ED, OR age≥ 40 years and ≥1 HF risk factor:
Exclusion Criteria:
During each month-long Intervention period, an AI-assisted POCUS tool will be available for ED physicians use, at their discretion, to assess left ventricular ejection fraction (LVEF) and diastolic function in patients presenting to the ED with suspected HF. The AI-automated echocardiogram report may be used in the referral pathway to the HF clinic if deemed clinically appropriate.
Device: AI-assisted point-of-care ultrasound (POCUS)
During each month-long Control period, the ED physicians will manage patients as close to "true" usual care as possible. There is no "placebo" arm. No actions will be undertaken to impede or prohibit care in the usual care arm.
ED physicians at both sites will be provided with 1 session of in person training in the use of the AI-assisted POCUS device within 4 weeks of randomization including, * Device set up * Demo of patient exam with POCUS device (to be used within its CE/Health Canada marked intended purpose or where deemed clinically appropriate by the treating physician). * Generation of AI-automated echocardiogram report for LVEF and diastolic dysfunction.
Feasibility of AI Assisted Point of Care Echocardiography Implementation
Proportion of eligible patients successfully undergoing AI assisted echo assessment at the point of care.
Time frame: During the enrollment period.
Diagnosis of heart failure (HF) within 90 days
Time frame: At 90 days.
Downstream health care resource utilization at 90 days and 1 year (e.g. rates of requests for echocardiography, cardiology referral, primary care appointments, HF hospitalization).
Time frame: At 90 days and 1 year.
Proportion of patients with HF receiving GDMT within 90 days
Time frame: At 90 days.
Difference in ratio of the incidence of diagnoses of HF via hospital admission-based versus community-based pathways
Time frame: At 90 days.
Uptake and utilization: differential rates of uptake and utilization of AI Assisted echocardiography in the emergency department
Time frame: During the enrollment period.
Determinants of uptake and utilization of AI assisted echocardiography in the emergency department (clinician questionnaire)
Time frame: During the enrollment period.
No study locations are listed for this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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