Angina, Unstable, Atrial Fibrillation (AF), Heart Diseases
Conditions
Keywords
Atrial Fibrillation, FAPO, PAOF, Telemonitoring, Digital Health, Arrhythmias
Brief 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.
Interventions
DEVICESmartwatch - all data
Single-lead ECG, blood pressure (BP), oxygen saturation (SpO2), and continuous heart rate (HR).
DEVICEPortable holter system
continuous ECG monitoring for 14 days for comparison with the data from the smartwatch
PROCEDURETelemonitoring
Remote consultations triggered by critical alerts based on predefined thresholds.
OTHERAI Model Development
Data analysis using artificial intelligence for prioritization of patients based on health data collected from wearables.
DEVICESmartwatch - ECG and HR
Single-lead ECG and continuous heart rate (HR)
Sponsors
Samsung Eletrônica da Amazônia Ltda
University of Sao Paulo
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
ECG Reader: The ECG reader will analyze the ECGs without access to identifiable participant information, ensuring that the interpretation of data is done blindly, without bias related to the patient's identity. AI Model Developer: The developer will also work with anonymized data, meaning they will not have access to personal information of the participants, ensuring the integrity and confidentiality of the data during model development.
Intervention model description
FAPO-2 adopts a prospective, single-group interventional study model in which all participants are remotely monitored using both the smartwatch and a portable holter system. The intervention consists of a structured teleconsultation model triggered by predefined clinical thresholds and critical patterns identified through continuous data integration on the FAPO-SI³ platform. Physiological and biometric data are collected viaHealth applications and transmitted daily (D+1) to the clinical team for near-real-time review. Upon detection of critical events or out-of-range parameters, the system automatically generates alerts that prompt nurse- or physician-led teleconsultations. During these teleconsultations, patient symptoms are evaluated, medication regimens may be adjusted, and decisions are made regarding the need for in-person clinical evaluation.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.); * Low or no risk of skin injury, based on Braden Scale clinical criteria or clinical team assessment
Exclusion criteria
* 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; * Presence of implanted cardiac devices, such as pacemakers, defibrillators, or cardiac resynchronization devices, which prevent ECG acquisition via smartwatch; * Diagnosis of conditions associated with narrowing or obstruction of the aorta and subclavian arteries (e.g., Stanford Type A chronic aortic dissection, Takayasu arteritis, Subclavian Steal Syndrome, or Kawasaki disease), which may cause discrepancies in blood pressure between upper limbs and interfere with study assessments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and number of Atrial Fibrillation (AF) events detected | During the monitoring period for each group, as specified (14-45 days depending on group) | 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. |
| Number of critical health alerts generated by the FAPO-SI³ platform | During the monitoring period for each group, as specified (14-45 days depending on group) | 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. |
| Patient risk classification generated by the AI model | During the monitoring period for each group, as specified (14-45 days depending on group) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient risk classification generated by the AI model | During the monitoring period for each group, as specified (14-45 days depending on group) | 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. |
| Adverse events related to device use | From enrollment through the monitoring period, up to 45 days depending on study group | Incidence of device-related adverse events including skin lesions (MARSI), allergic reactions, and discomfort (graded using validated scales) reported during the monitoring period. |
Countries
Brazil
Contacts
Primary ContactFabio B Jatene, PhD, MD
Backup ContactRosangela Monteiro, PhD
Outcome results
None listed