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Study identifier: NCT07113223 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Determining Efficacy of an Artificial Intelligence-based System for Heart Failure Detection Through Interpretation of Electrocardiograms (DECISION)

Condition: Heart Failure · Cardiovascular Risk Factors  ·  Sponsor: Idoven 1903 S.L.

PhaseNA
Planned participants1968
Who can joinAll sexes, 65 Years to no upper limit
Healthy volunteersNo

About this study

The DECISION trial aims to evaluate the efficacy of an artificial intelligence (AI)-powered system, Willem™, for improving the detection of heart failure (HF) in primary care settings by interpreting electrocardiograms (ECGs). The study seeks to answer whether AI-assisted ECG interpretation enhances diagnostic accuracy and clinical outcomes compared to standard ECG evaluation in patients with suspected HF or those at high risk. This multicenter, pragmatic, randomized clinical trial involves two groups: patients receiving AI-assisted ECG analysis and those undergoing standard ECG evaluation. The study's primary analysis will compare the diagnostic performance of AI-assisted ECG versus standard ECG using sensitivity, specificity, and predictive value metrics. Secondary analyses will evaluate healthcare resource utilization, clinical outcomes, and usability feedback from healthcare providers. Results will inform the potential integration of AI-assisted ECG in routine primary care workflows for earlier HF detection and better resource allocation.

This description comes directly from the study's public registry record.

Talk to the study team

Juan Francisco Delgado Jiménez, MD, PhD  ·  +34917792640  ·  juan.delgado@salud.madrid.org

Always discuss trial participation with your own doctor first.

Locations (5)

Hospital General Universitario Gregorio MarañónMadrid, SpainRecruiting
Hospital Universitario 12 de OctubreMadrid, SpainRecruiting
Primary Care: Gerencia Asistencial Atención Primaria MadridMadrid, SpainRecruiting
Hospital Universitario Marqués de ValdecillaSantander, SpainRecruiting
Region StockholmStockholm, SwedenRecruiting

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Source record: clinicaltrials.gov/study/NCT07113223