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Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease
NCT05442203 · View on ClinicalTrials.gov ↗
Study Summary
Atrial fibrillation is an abnormal beating of the heart that can lead to stroke or heart failure. Structural heart diseases are conditions that affect the heart valves or heart muscle and can cause permanent heart damage if left untreated. Sometimes people have atrial fibrillation or structural heart disease and do not know it. The purpose of this study is to evaluate two devices that can predict who has or may develop atrial fibrillation or structural heart disease based on the results of an electrocardiogram.
Conditions Studied
Interventions
- DEVICE Zio Patch Monitor
- DEVICE Echocardiogram
Study Locations (3)
Michigan
- Corewell Health — Grand Rapids
Ohio
- TriHealth — Cincinnati
Pennsylvania
- Geisinger Medical Center — Danville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2022-09-07 |
| Est. Completion | 2025-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05442203
The ClinicalTrials.gov registry entry for NCT05442203 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tempus AI, which has 12 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions — of which Zio Patch Monitor is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05442203 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Michigan, Ohio, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05442203 about?
NCT05442203 is a clinical study titled "Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease". Atrial fibrillation is an abnormal beating of the heart that can lead to stroke or heart failure. Structural heart diseases are conditions that affect the heart valves or heart muscle and can cause permanent heart damage if left untreated. Sometimes people have atrial fibrillation or structural hear...
What is the current status of trial NCT05442203?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 1,000 participants. The study started on 2022-09-07. Estimated completion is 2025-07.
What conditions does trial NCT05442203 study?
This clinical trial studies the following conditions: Atrial Fibrillation, Structural Heart Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05442203?
The interventions under investigation include: Zio Patch Monitor (DEVICE), Echocardiogram (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05442203?
This trial is sponsored by Tempus AI, which has 12 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05442203 being conducted?
This trial has 3 study locations across Michigan, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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