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RECRUITING
NCT07113223
NA

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

Sponsor: Idoven 1903 S.L.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1968

Start Date

2025-07-23

Completion Date

2026-09

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

DEVICE

Willem™ platform ECG assessment

AI-assisted ECG analysis via the Willem™ platform

Locations (5)

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