ECG-based AI Screening for Cases of Undiagnosed Moderate-to-Severe Aortic Stenosis in the Primary Care Setting

ClinicalTrials.gov ID: NCT07827105

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The goal of this observational study is to learn whether AccurKardia's AK-AVS algorithm can help identify moderate-to-severe aortic stenosis (AS), a narrowing of the heart's aortic valve, in older adults who have not yet been diagnosed. The main question it aims to answer is if AK-AVS can correctly identify participants who have undiagnosed moderate-to-severe aortic stenosis, based on a routine heart tracing (electrocardiogram). Approximately 4,000 electrocardiograms (ECGs) already collected as part of routine primary care, urgent care, or emergency room visits will be reviewed by the AK-AVS algorithm. Patients whose ECGs are flagged as showing a possible sign of aortic stenosis will be invited to complete a symptom questionnaire, a physical exam, and heart ultrasound (echocardiogram) to confirm whether aortic stenosis is present.

Study identification

NCT ID: NCT07827105
Recruitment status: Enrolling by invitation
Study type: Observational
Phase: Not listed
Lead sponsor: AccurKardia, Inc.; Industry
Enrollment: 4,000 participants

Conditions and interventions

Conditions

Aortic Stenosis

Interventions

AK-AVS Device

Device

Eligibility (public fields only)

Age range: 65 Years and older
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 21, 2026 (Actual)
Primary completion: Feb 2027 (Estimated)
Completion: Mar 2027 (Estimated)
Last update posted: Sep 18, 2026

2026 – 2027

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
UC Irvine Health	Orange	California	92868	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07827105, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 18, 2026 · Synced Nov 14, 2026