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

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.

NCT Number	NCT07113223
Lead Sponsor	Idoven 1903 S.L. Collaborators: Fundación para la Investigación Biomédica del Hospital 12 de Octubre, Fundación para la Investigación Biomédica del Hospital Gregorio Maranon, Fundación para la Investigación e Innovación Biosanitaria de Atención Primaria de la Comunidad de Madrid (FIIBAP), Instituto de Investigación Marqués de Valdecilla, Karolinska Institutet, Region Stockholm, AstraZeneca, Servicio Madrileno De Salud (SERMAS)
Conditions	Heart Failure, Cardiovascular Risk Factors
Enrollment	1,968 participants
Start Date	2025-07-23
Primary Completion	2026-09 (estimated)
Study Completion	2027-03 (estimated)
Updated on ClinicalTrials.gov	2026-07-20