FAPO-2: Cardiac Patient Monitoring Tool for Clinical Observation and Arrhythmia Detection
Trial ID: NCT07174206
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-02-07
Completion date: 2026-02-28
Sponsor: University of Sao Paulo
Collaborators: Samsung Eletrônica da Amazônia Ltda
Conditions: Heart Diseases; Atrial Fibrillation (AF); Angina, Unstable
Interventions: Smartwatch - all data; Portable holter system; Telemonitoring; AI Model Development; Smartwatch - ECG and HR
Locations: Instituto do Coracao, HCFMUSP
Countries: Brazil
Enrollment: 520
Age range: 22 Years - None
Sex: ALL

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.

Eligibility criteria:
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.

Outcomes:
Incidence and number of Atrial Fibrillation (AF) events detected; Number of critical health alerts generated by the FAPO-SI³ platform; Patient risk classification generated by the AI model