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Enrolling by invitationNCT06749145Updated Oct 6, 2026

Deep Learning Enhanced Detection of Aortic Stenosis - The DETECT-AS-Diagnostic Study

An interventional study of Portable 1-lead electrocardiogram and Point-of-care ultrasound in Aortic Stenosis, sponsored by Yale University. Enrolling by invitation at 3 sites in United States. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Yale University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
410
Allocation
Randomized
Ages
70 Years and older
Sex
All
01

Study summary

The DETECT-AS Diagnostic Study will assess the performance of artificial intelligence (AI) risk predictions to detect aortic stenosis using results from portable electrocardiogram (ECG) and cardiac ultrasound devices.

02

Conditions studied

  • Aortic Stenosis

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Keywords

  • aortic stenosis
  • artificial intelligence
03

In context

Aortic Valve Stenosis

985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.

This study's planned enrollment of 410 is above the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age 70 years or older
  • Attending a routine outpatient primary care clinic at one of the three enrollment sites

Exclusion criteria

Exclusion Criteria:

  • Opted out of research studies
  • Non-English speaking
  • Urgent or emergent visits, defined as a visit for an illness or injury that needs attention quickly or is life-threatening
  • Any echocardiogram within 12 months of clinic visit
  • Prior history of moderate or severe AS
  • Prior history of aortic valve replacement or repair, including transcatheter and surgical AVR with either a bioprosthetic or mechanical valve
  • Presence of implantable cardiac devices, including permanent cardiac pacer, implantable cardioverter-defibrillator, or left ventricular assist device
  • Prior heart transplant
  • History of dementia
  • Documented life expectancy of \<1 year or current participation in hospice services.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
410 participants (estimated)

Study arms

  • Experimental
    Intervention

    The intervention arm will undergo sequential screening for aortic stenosis using portable 1-lead electrocardiograms (ECGs), followed by point-of-care ultrasound (POCUS), if indicated, by artificial intelligence (AI)-based risk algorithms.

    Diagnostic Test: Portable 1-lead electrocardiogram · Diagnostic Test: Point-of-care ultrasound · Other: AI-ECG risk algorithm · Other: AI-POCUS

  • Sham comparator
    Control

    The control arm will undergo a portable 1-lead electrocardiogram (ECG), with 10% randomly assigned to undergo point-of-care ultrasound (POCUS).

    Diagnostic Test: Portable 1-lead electrocardiogram · Diagnostic Test: Point-of-care ultrasound

Interventions

  • Diagnostic testPortable 1-lead electrocardiogram

    Portable 1-lead electrocardiogram (ECG) performed with the FDA-approved AliveCor KardiaMobile device.

  • Diagnostic testPoint-of-care ultrasound

    Point-of-care ultrasound performed with the FDA-approved VScan Air device.

  • OtherAI-ECG risk algorithm

    Artificial intelligence (AI) risk algorithm for aortic stenosis using a 1-lead electrocardiogram

  • OtherAI-POCUS

    Artificial intelligence (AI) risk algorithm for aortic stenosis using cardiac ultrasound plax videos.

06

What researchers measure

Primary outcomes

  1. Number of participants diagnosed with advanced aortic stenosis (AS) by transthoracic echocardiogram (TTE)

    The number of participants diagnosed with advanced AS by TTE at 12 months. Diagnosis of advanced AS is defined as diagnosis of moderate or severe AS as documented in the participant's electronic health record (EHR) at 12 months and adjudication of outcome via review of echocardiographic reports and videos performed by blinded members of the echocardiographic lab at the coordinating center.

    Time frame: Until 12 months from the baseline visit

07

Study locations

3 sites
  • Yale New Haven Health System
    New Haven, Connecticut 06519, United States
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
  • The Methodist Hospital Research Institute
    Houston, Texas 77030, United States
08

References and documents

Individual participant data

Plan to share: Yes — A de-identified dataset will be made available following publication of primary results.

Supporting information: Study protocol, Sap, Icf, Analytic code

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06749145
Lead sponsor
Yale University
Collaborators
National Institute on Aging (NIA), Icahn School of Medicine at Mount Sinai, The Methodist Hospital Research Institute
Responsible party
Sponsor
First posted
Dec 27, 2024
Start date
Sep 16, 2025
Primary completion
Aug 31, 2028 (estimated)
Completion
Aug 31, 2028 (estimated)
Last update
Oct 6, 2026

Study contacts

Rohan Khera, MD, MS
principal investigator · Yale University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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