FAPO-2: Cardiac Patient Monitoring Tool for Clinical Observation and Arrhythmia Detection

NARecruitingINTERVENTIONAL
Enrollment

520

Participants

Timeline

Start Date

February 7, 2025

Primary Completion Date

January 31, 2026

Study Completion Date

February 28, 2026

Conditions
Heart DiseasesAtrial Fibrillation (AF)Angina, Unstable
Interventions
DEVICE

Smartwatch - all data

Single-lead ECG, blood pressure (BP), oxygen saturation (SpO2), and continuous heart rate (HR).

DEVICE

Portable holter system

continuous ECG monitoring for 14 days for comparison with the data from the smartwatch

PROCEDURE

Telemonitoring

Remote consultations triggered by critical alerts based on predefined thresholds.

OTHER

AI Model Development

Data analysis using artificial intelligence for prioritization of patients based on health data collected from wearables.

DEVICE

Smartwatch - ECG and HR

Single-lead ECG and continuous heart rate (HR)

Trial Locations (1)

05403-900

RECRUITING

Instituto do Coracao, HCFMUSP, São Paulo

All Listed Sponsors
collaborator

Samsung Eletrônica da Amazônia Ltda

UNKNOWN

lead

University of Sao Paulo

OTHER