FAPO-2: Cardiac Patient Monitoring Tool for Clinical Observation and Arrhythmia Detection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorUniversity of Sao Paulo
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with cardiovascular disease, of both sexes, aged over 22 years;
Provision of informed consent through signature of the Informed Consent Form (ICF);
Assentation to adhere to study procedures and requirements;
Patients indicated for outpatient follow-up due to a cardiovascular condition, or with clinical parameters indicating the need for conventional surgical or catheter-based interventions (e.g., catheter ablation for arrhythmias, transcatheter aortic valve implantation, percutaneous coronary intervention, etc.);
Disqualifiers
Presence of skin conditions, such as vitiligo, lupus, or atopic dermatitis, as well as tattoos on the wrist that may interfere with the smartwatch's optical sensor readings;
Known sensitivity or history of allergic reactions to components of the wearable devices or related items, such as adhesives or electrodes;
Inability to properly use the wearable monitoring devices due to physical, cognitive, or technological limitations;
Presence of a peripherally inserted central catheter (PICC) or arteriovenous fistula;
Trial design
Design model
Parallel
Treatments tested in this trial
Smartwatch - all data
DeviceSingle-lead ECG, blood pressure (BP), oxygen saturation (SpO2), and continuous heart rate (HR).
Portable holter system
Devicecontinuous ECG monitoring for 14 days for comparison with the data from the smartwatch
Telemonitoring
Procedure/SurgeryRemote consultations triggered by critical alerts based on predefined thresholds.
AI Model Development
Other interventionData analysis using artificial intelligence for prioritization of patients based on health data collected from wearables.
Smartwatch - ECG and HR
DeviceSingle-lead ECG and continuous heart rate (HR)
Treatment groups
520 Participants
are divided into 4 treatment groupsGroup A: Pilot GroupExperimental treatment 4 interventions
Group B: Extensive Ambulatory Monitoring GroupActive comparator 4 interventions
Group C: Extensive Post-Intervention MonitoringActive comparator 4 interventions
Group D: Optimized Outpatient MonitoringActive comparator 4 interventions
Trial outcomes
Primary outcomes
1
Incidence and number of Atrial Fibrillation (AF) events detected
Incidence and total number of AF events detected, stratified by study group and device type (smartwatch, portable Holter). This allows assessment of AF detection rate across different monitoring protocols and devices during the follow-up period.
Time frame
During the monitoring period for each group, as specified (14-45 days depending on group)2
Number of critical health alerts generated by the FAPO-SI³ platform
Alerts categorized by physiological parameter: blood pressure (BP), heart rate (HR), and oxygen saturation (SpO₂). Mean clinical response time to alerts will be calculated per patient during their respective monitoring period, allowing assessment of platform responsiveness and clinical workflow efficiency.
Time frame
During the monitoring period for each group, as specified (14-45 days depending on group)3
Patient risk classification generated by the AI model
Distribution of patients across AI-generated risk categories (e.g., low, moderate, high) based on physiological and biometric data collected from the smartwatch and portable Holter system during the monitoring period.
Time frame
During the monitoring period for each group, as specified (14-45 days depending on group)Secondary outcomes
1
Patient risk classification generated by the AI model
Distribution of patients across AI-generated risk categories adapted from the Manchester Triage System. The algorithm will classify patients into risk levels (e.g., immediate, very urgent, urgent, standard, non-urgent) based on physiological and biometric data collected from the smartwatch and portable Holter system during the monitoring period.
Time frame
During the monitoring period for each group, as specified (14-45 days depending on group)2
Adverse events related to device use
Incidence of device-related adverse events including skin lesions (MARSI), allergic reactions, and discomfort (graded using validated scales) reported during the monitoring period.
Time frame
From enrollment through the monitoring period, up to 45 days depending on study groupSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Sao Paulo
Lead sponsor
Samsung Eletrônica da Amazônia Ltda
Collaborator
Source ClinicalTrials.gov