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

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.

Conditions

• Heart Failure
• Cardiovascular Risk Factors

Interventions

DEVICE

Willem™ platform ECG assessment

AI-assisted ECG analysis via the Willem™ platform

Sponsors & Collaborators

• Fundación para la Investigación Biomédica del Hospital 12 de Octubre

  collaborator UNKNOWN

• Fundación para la Investigación Biomédica del Hospital Gregorio Maranon

  collaborator OTHER

• Fundación para la Investigación e Innovación Biosanitaria de Atención Primaria de la Comunidad de Madrid (FIIBAP)

  collaborator UNKNOWN

• Instituto de Investigación Marqués de Valdecilla

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• Region Stockholm

  collaborator OTHER_GOV

• AstraZeneca

  collaborator INDUSTRY

• Servicio Madrileno De Salud (SERMAS)

  collaborator UNKNOWN

• Idoven 1903 S.L.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-23

Primary Completion

2026-07-31

Completion

2026-09-30

Countries

• Spain
• Sweden

Study Locations