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Life sciences · Interventional Study
ClinicalTrials.gov · November 4, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07113223). This is a study registration, not published results. Lead sponsor: Idoven 1903 S.L.. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 1968 participants (ESTIMATED). Conditions: Heart Failure, Cardiovascular Risk Factors. Interventions: DEVICE: Willem™ platform ECG assessment. Primary outcome measures: Device performance in patients with suspected Heart Failure , After performing the transthoracic echocardiography (TTE) in Visit 3 (7 days after screening). Brief 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.