NCT07174206

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 520 (estimated)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2025-02-07
• Primary completion: 2026-01-31
• Completion: 2026-02-28
• First posted: 2025-09-15
• Last updated: 2025-09-15

Locations

1 site across 1 country: Brazil