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

University of Sao Paulo

Status: Enrolling

Conditions: Angina, Unstable; Atrial Fibrillation (AF); Heart Diseases

Treatments: Procedure: Telemonitoring; Other: AI Model Development; Device: Portable holter system; Device: Smartwatch - all data; Device: Smartwatch - ECG and HR

Study type: Interventional

Funder types: Other

Identifiers

NCT07174206

80963624.2.0000.0068

Details and patient eligibility

About

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.

Enrollment: 520 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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520 participants in 4 patient groups

Pilot Group

Experimental group

Description:

Healthy volunteers monitored for \~14±3 days using both a smartwatch and a portable holter system to validate usability, skin tolerability, signal integrity, and data flow within the platform.

Treatment:

Device: Smartwatch - all data

Device: Portable holter system

Other: AI Model Development

Procedure: Telemonitoring

Extensive Ambulatory Monitoring Group

Active Comparator group

Description:

Patients with chronic cardiovascular diseases monitored over 45±3 days. For 30 days, participants use the smartwatch to collect blood pressure, oxygen saturation (SpO2), heart rate (HR), and sigle-lead ECG. Also, for 15 days, participants use both smartwatch (HR and ECG only) and portable holter system simultaneously, with the patch providing continuous ECG monitoring.

Treatment:

Device: Smartwatch - all data

Device: Portable holter system

Other: AI Model Development

Procedure: Telemonitoring

Extensive Post-Intervention Monitoring

Active Comparator group

Description:

Patients who have recently undergone minimally invasive cardiovascular procedures such as angioplasty, transcatheter aortic valve implantation (TAVI), or catheter ablation. Monitoring occurs over 45±3 days. For 30 days, participants use the smartwatch to collect blood pressure, oxygen saturation (SpO2), heart rate (HR), and single-lead ECG. Also, for 15 days, both the smartwatch (HR and ECG only) and the portable holter system are used simultaneously, with the portable holter system providing continuous ECG monitoring.

Treatment:

Device: Smartwatch - all data

Device: Portable holter system

Other: AI Model Development

Procedure: Telemonitoring

Optimized Outpatient Monitoring

Active Comparator group

Description:

Patients with stable chronic cardiac disease monitored for 15±3 days using both the smartwatch captures heart rate and single-lead ECG, while the portable holter system provides continuous ECG monitoring.

Treatment:

Device: Smartwatch - ECG and HR

Device: Portable holter system

Other: AI Model Development

Procedure: Telemonitoring