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NCT06511505 · ClinicalTrials.gov record · last posted 2026-08-20

NOrthwestern Tempus AI-enaBLed Electrocardiography (NOTABLE) Trial

Study acronym: NOTABLE
StatusRecruiting
PhaseNot applicable
Started2024-09-16
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
The goal of this clinical trial is to determine if a machine learning/artificial intelligence (AI)-based electrocardiogram (ECG) algorithm (rECHOmmend and ECG-AF) can identify undiagnosed cardiovascular disease in patients. It will also examine the safety and effectiveness of using this AI-based tool in a clinical setting. The main questions it aims to answer are: 1. Can the AI-based ECG algorithm improve the detection of atrial fibrillation and structural heart disease? 2. How does the use of this algorithm affect clinical decision-making and patient outcomes? Researchers will compare the outcomes of healthcare providers who receive the AI-based ECG results to those who do not. Participants (healthcare providers) will: Be randomized into two groups: one that receives AI-based ECG results and one that does not. In the intervention group, receive an assessment of their patient's risk of atrial fibrillation or structural heart disease with each ordered ECG. Decide whether to perform further clinical evaluation based on the AI-generated risk assessment as part of routine clinical care.

Protocol amendment history 7 changes detected by DataLookout

2026-08-21
Primary completion pushed: 2026-09 → 2027-09
2026-08-21
Completion pushed: 2027-03 → 2028-09
2026-08-20
Trial status changed: Unknown → Recruiting
2026-08-20
Primary endpoint(s) modified
WasRate of new CV diagnoses at 6 months
NowIncidence of New Atrial Fibrillation Diagnosis, Incidence of New Cardiovascular Diagnosis (Overall Composite: AF + SHD), Incidence of New Structural Heart Disease Diagnosis (Composite)
2026-08-20
Primary completion pushed: 2025-08-03 → 2026-09
2026-08-20
Completion pushed: 2026-02-03 → 2027-03
2026-08-02
Trial status changed: Not Yet Recruiting → Unknown
Trial Details
NCT Number NCT06511505
Lead Sponsor Northwestern University
Collaborators: Tempus AI
Conditions Atrial Fibrillation, Cardiovascular Diseases, Arrhythmia, Valvular Disease
Enrollment 1,000 participants
Start Date 2024-09-16
Primary Completion 2027-09 (estimated)
Study Completion 2028-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-20