Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)

Conditions

• Aortic Stenosis
• Left Ventricular Diastolic Dysfunction
• Mitral Regurgitation
• Valvular Heart Disease Patients

Eligibility Criteria

Sex

ALL

Age

65 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Kosmos Torso-One AI-guided Point-of-Care Ultrasound (EchoNous, Inc.) — DEVICE
  A single AI-guided handheld POCUS examination performed by trained clinic staff (medical or certified nursing assistants) during a routine primary care or geriatrics visit. Acquisition is standardized, including parasternal long- and short-axis and apical 3- and 4-chamber views, with 2D imaging, color Doppler, M-mode of the mitral valve, and continuous-wave Doppler of the aortic and mitral valves. Images are transmitted to a central echocardiographic core laboratory, which screens for adequacy; adequate studies are analyzed by pre-specified AI algorithms based on 2017 ASE guidelines, blinded to arm assignment. A positive screen is defined as moderate or greater valvular heart disease or left ventricular ejection fraction of 50% or less. Positive results are communicated to the participant's primary care provider with a recommendation to consider confirmatory TTE; ordering remains at provider discretion, and the study team facilitates completion within 90 days of index visit.

Study Details

Heart valve disease and weakened heart muscle (left ventricular systolic dysfunction) are common in older adults and often go undetected until serious complications such as heart failure develop. Detection currently depends on a clinician hearing a murmur and then ordering an echocardiogram, which is easily missed or delayed. This study tests whether a brief, artificial intelligence (AI)-guided handheld heart ultrasound - point-of-care ultrasound, or POCUS - performed by trained clinic staff during a routine visit identifies these conditions earlier than usual care. Primary care and geriatrics providers, rather than individual patients, are assigned by chance to one of two groups. Patients seen by providers in the AI-ultrasound group are offered a POCUS scan and a one-time blood test at their regular visit, and are referred for a confirmatory echocardiogram if the scan is abnormal. Patients seen by providers in the usual care group receive standard clinic care. Researchers will compare how often previously undiagnosed structural heart disease is newly identified in each group.

Key Dates

First listed

Aug 10, 2026

Start date

Aug 1, 2026

Status verified

Aug 2026

Primary completion

Jun 1, 2028

Completion

Dec 1, 2028

Study Design

Enrollment

1,088 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Arms

• Experimental: AI-POCUS Screening
  Trained clinic staff perform AI-guided point-of-care ultrasound using the Kosmos Torso-One device on eligible patients during routine primary care or geriatrics visits. Patients with ≥ moderate valvular heart disease or EF ≤50% are referred for confirmatory echocardiography within 90 days.
• No Intervention: Usual Care
  Eligible patients receive standard provider-driven care. Echocardiography referral occurs per routine clinical indications such as auscultated murmur or patient-reported symptoms.

Primary Outcome Measure

New diagnosis of structural heart disease (≥ moderate valvular heart disease or left ventricular systolic dysfunction) [ Time Frame: 90 days from index clinic visit ]

Central Contacts

• Dharam J Kumbhani, MD, SM, MRCP, FACC, FAHA, FSCA
  214-645-7508
  [email protected]
• Ritika Dhruve, MBBS, MPH
  [email protected]

Locations (2)

Find similar trials in Dallas, TX

Related Studies

• PARTNER 3 Trial - Aortic Valve-in-Valve
  Recruiting · Edwards Lifesciences · Phoenix, Arizona
• An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System
  Recruiting · HighLife SAS · Tucson, Arizona
• The ENCIRCLE Trial
  Recruiting · Edwards Lifesciences · Huntsville, Alabama
• The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).
  Recruiting · Mayra Guerrero · Gilbert, Arizona