NCT07113223

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,968 (estimated)
• Sponsor: Idoven 1903 S.L. · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Heart failure (HF) is a prevalent and underdiagnosed condition with high morbidity and mortality. Up to 50% of HF cases remain undetected, often due to subtle or absent symptoms in early stages. Early diagnosis is critical to improving outcomes, reducing hospitalizations, and alleviating healthcare costs. While ECGs are a cornerstone in HF diagnosis, their interpretation in primary care can be challenging, leading to diagnostic delays. Artificial intelligence (AI) has emerged as a promising tool to support clinicians by enhancing ECG interpretation. In this regard, the DECISION trial evaluates the Willem™ platform, an AI-powered decision-support system, to improve HF detection. Willem™ uses a proprietary database to analyze ECGs, identifying over 80 cardiac patterns with high accuracy. This study hypothesizes that AI-assisted ECG improves HF detection compared to standard ECG interpretation. Therefore, the main goal of the DECISION trial is to assess the diagnostic performance of AI-assisted ECG in detecting structural and functional cardiac abnormalities indicative of HF. This multicenter, randomized trial includes primary care centers (PCCs) in Spain and Sweden, randomized into two groups: an intervention group using AI-assisted ECG and a control group using standard ECG. AI outputs will be available for physicians in the intervention group as supplementary information during decision making. Primary outcomes focus on the accuracy of HF detection confirmed by transthoracic echocardiograms (TTE). Secondary outcomes include healthcare resource utilization, clinical outcomes, and physician satisfaction. The results will inform whether AI can be integrated into primary care workflows to optimize HF diagnosis and management.

Conditions

• Heart Failure
• Cardiovascular Risk Factors

Interventions

Type	Name	Description
DEVICE	Willem™ platform ECG assessment	AI-assisted ECG analysis via the Willem™ platform

Timeline

• Start date: 2025-07-23
• Primary completion: 2026-07-01
• Completion: 2026-09-01
• First posted: 2025-08-08
• Last updated: 2026-03-31

Locations

5 sites across 2 countries: Spain, Sweden