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Clinical Trial

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

NCT: NCT07827105 · ENROLLING_BY_INVITATION

NCT IDNCT07827105
StatusENROLLING_BY_INVITATION
Start Date2026-08-21
Completion2027-03
SponsorAccurKardia, Inc. (INDUSTRY)
First posted
Last updated

Brief Summary

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.

Frequently Asked Questions

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

ECG-based AI Screening for Cases of Undiagnosed Moderate-to-Severe Aortic Stenosis in the Primary Care Setting is a clinical trial registered under NCT07827105. Current status: ENROLLING_BY_INVITATION.

What is the status of NCT07827105?

The current status of NCT07827105 (ECG-based AI Screening for Cases of Undiagnosed Moderate-to-Severe Aortic Stenosis in the Primary Care Setting) is: ENROLLING_BY_INVITATION.

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

ECG-based AI Screening for Cases of Undiagnosed Moderate-to-Severe Aortic Stenosis in the Primary Care Setting started on 2026-08-21.

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Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.