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

Summary

The FAPO-2 study (Patient Monitoring Tool for Clinical Observation and Arrhythmia Detection) is a prospective, interventional, non-randomized study designed to evaluate the feasibility, usability, clinical effectiveness, and cost-efficiency of a wearable-enabled remote monitoring strategy in adult cardiac patients. The intervention consists of active clinical management of patients via teleconsultations, triggered by automated alerts generated through wearable data integrated into a centralized digital platform. FAPO-2 will include patients with chronic cardiovascular conditions and those undergoing recent minimally invasive interventions. The central objective is to validate a structured model for early arrhythmia detection, remote risk stratification, and timely clinical action. A total of 520 patients aged ≥22 years will be enrolled, stratified by sex (1:1), and followed at the Heart Institute (InCor) of the University of São Paulo. Participants will be allocated into one of four protocol groups:

Group 1 - Pilot (n=15): Healthy volunteers monitored for \~14±3 days using both the smartwatch and a portable holter system to validate usability, skin tolerability, signal integrity, and data flow within the platform.

Group 2 - Extensive Outpatient Monitoring (n=150): Patients with chronic cardiovascular diseases monitored over a 45-day period. During 30 days, monitoring will be performed using a smartwatch to capture blood pressure, oxygen saturation, heart rate, and single-lead ECG. For 15 days, participants will use both the smartwatch (for HR and ECG) and a portable holter system.

Group 3 - Extensive Post-Intervention Monitoring (n=50): Patients recently undergoing procedures such as angioplasty, TAVI, or ablation, following the same monitoring protocol as Group 2.

Group 4 - Optimized Outpatient Monitoring (n=305): Patients with stable chronic cardiac disease monitored for 15±3 days, using both devices simultaneously for HR and ECG (smartwatch) and portable holter system.

Conditions

• Heart Diseases
• Atrial 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)

Sponsors & Collaborators

• Samsung Eletrônica da Amazônia Ltda

  collaborator UNKNOWN

• University of Sao Paulo

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

22 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-07

Primary Completion

2026-01-31

Completion

2026-02-28

Countries

• Brazil

Study Locations