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Valvular Heart Disease Patients / Aortic Stenosis / Mitral Regurgitation · Interventional Study
ClinicalTrials.gov · August 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned, not-yet-recruiting cluster-randomized trial comparing AI-guided point-of-care ultrasound to usual care for detection of structural heart disease in older adults in primary care and geriatrics settings. No results are available from this registry record; the trial is designed to evaluate whether POCUS screening increases detection of clinically significant valvular disease and left ventricular systolic dysfunction within 90 days, with secondary assessment of implementation outcomes over two years.
Interventional, Randomized, Parallel, Single masking, Screening purpose. Valvular Heart Disease Patients, Aortic Stenosis, Mitral Regurgitation, Left Ventricular Diastolic Dysfunction; age from 65 Years; to 85 Years. Intervention: AI-POCUS Screening. Compared with: Usual Care — No Intervention. n = 1,440. 3 sites: United States.
This is a planned, not-yet-recruiting cluster-randomized trial comparing AI-guided point-of-care ultrasound to usual care for detection of structural heart disease in older adults in primary care and geriatrics settings. No results are available from this registry record; the trial is designed to evaluate whether POCUS screening increases detection of clinically significant valvular disease and left ventricular systolic dysfunction within 90 days, with secondary assessment of implementation outcomes over two years.
This is a registry record only; no results, efficacy data, safety data, or outcome analyses have been reported. Primary endpoint is diagnosis within 90 days; longer-term clinical outcomes (symptom relief, mortality, complications) are not primary measures.
The source did not state who this applies to in practice.
This is a clinical trial registry record describing a planned interventional study with no results posted; enrollment has not yet begun, so no evidence on efficacy or safety exists.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07756398). This is a study registration, not published results. Lead sponsor: University of Texas Southwestern Medical Center. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 1440 participants (ESTIMATED). Conditions: Valvular Heart Disease Patients, Aortic Stenosis, Mitral Regurgitation, Left Ventricular Diastolic Dysfunction. Interventions: DEVICE: Kosmos Torso-One AI-guided Point-of-Care Ultrasound (EchoNous, Inc.). Primary outcome measures: New diagnosis of structural heart disease (≥ moderate valvular heart disease or left ventricular systolic dysfunction) , 90 days from index clinic visit. Brief summary: Structural heart disease (SHD), including valvular heart disease and left ventricular systolic dysfunction, is common in older adults and often goes undetected until symptoms or complications such as heart failure develop. Current detection relies on opportunistic clinical evaluation, including cardiac auscultation, which has limited sensitivity and is inconsistently performed, and echocardiography, which is accurate but resource-intensive. The IMPROVE trial (IMportance of Point-of-caRe ultrasOund for Early Detection of Valvular and Cardiac DiseasEs) evaluates whether an artificial intelligence-guided point-of-care ultrasound (POCUS) screening strategy, embedded in routine primary care and geriatrics ambulatory visits, increases detection of clinically significant SHD compared with usual care. Provider clusters at three health systems will be randomized 1:1 to the AI-POCUS screening strategy or usual care, and approximately 1,440 patients aged 65 years and older will be enrolled over 24 months. In the screening arm, trained clinic staff will acquire cardiac images using an AI-guided handheld ultrasound device; images will be analyzed by FDA-cleared AI software under core laboratory supervision, and patients with a positive screen will be referred to their primary care provider for consideration of a confirmatory transthoracic echocardiogram. The primary outcome is a new diagnosis of SHD (moderate or greater valvular disease, or left ventricular ejection fraction of 50% or less) confirmed by echocardiography within 90 days of the index visit. Secondary outcomes include recall rate, downstream testing and costs, cardiology or cardiac surgery referrals, and major adverse cardiac events over two years. The trial uses a type 1 hybrid effectiveness-implementation design and will concurrently assess the acceptability, feasibility, and determinants of AI-POCUS adoption in ambulatory practice.
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