Determining Efficacy of an Artificial Intelligence-based System for Heart Failure Detection Through Interpretation of Electrocardiograms: a Pragmatic Randomized Clinical Trial (DECISION)

Official Summary

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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: SINGLE
• Enrollment: 1,968 participants

Interventions

• DEVICE: Willem™ platform ECG assessment — AI-assisted ECG analysis via the Willem™ platform

Primary Outcomes

• Device performance in patients with suspected Heart Failure (After performing the transthoracic echocardiography (TTE) in Visit 3 (7 days after screening))

Secondary Outcomes

• Device performance in patients at cardiovascular risk but without Heart Failure symptoms (After performing the transthoracic echocardiography (TTE) in Visit 3 (7 days after screening))
• Device performance at 6 months after ECG (Six months after the ECG was performed)

Trial Locations

• Hospital General Universitario Gregorio Marañón, Madrid, Spain
• Hospital Universitario 12 de Octubre, Madrid, Spain
• Primary Care: Gerencia Asistencial Atención Primaria Madrid, Madrid, Spain
• Hospital Universitario Marqués de Valdecilla, Santander, Spain
• Region Stockholm, Stockholm, Sweden

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