FAPO-2: Cardiac Patient Monitoring Tool for Clinical Observation and Arrhythmia Detection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Sao Paulo
- Enrollment
- 520
- Locations
- 1
- Primary Endpoint
- Incidence and number of Atrial Fibrillation (AF) events detected
Study Overview
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.
Study Design
- Study Type
- Interventional
- 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.
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Pilot Group
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.
Intervention: Smartwatch - all data (Device)
Pilot Group
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.
Intervention: Portable holter system (Device)
Pilot Group
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.
Intervention: Telemonitoring (Procedure)
Pilot Group
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.
Intervention: AI Model Development (Other)
Extensive Ambulatory Monitoring Group
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.
Intervention: Smartwatch - all data (Device)
Extensive Ambulatory Monitoring Group
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.
Intervention: Portable holter system (Device)
Extensive Ambulatory Monitoring Group
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.
Intervention: Telemonitoring (Procedure)
Extensive Ambulatory Monitoring Group
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.
Intervention: AI Model Development (Other)
Extensive Post-Intervention Monitoring
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.
Intervention: Smartwatch - all data (Device)
Extensive Post-Intervention Monitoring
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.
Intervention: Portable holter system (Device)
Extensive Post-Intervention Monitoring
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.
Intervention: Telemonitoring (Procedure)
Extensive Post-Intervention Monitoring
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.
Intervention: AI Model Development (Other)
Optimized Outpatient Monitoring
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.
Intervention: Portable holter system (Device)
Optimized Outpatient Monitoring
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.
Intervention: Telemonitoring (Procedure)
Optimized Outpatient Monitoring
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.
Intervention: AI Model Development (Other)
Optimized Outpatient Monitoring
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.
Intervention: Smartwatch - ECG and HR (Device)
Outcomes
Primary Outcomes
Incidence and number of Atrial Fibrillation (AF) events detected
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Patient risk classification generated by the AI model(During the monitoring period for each group, as specified (14-45 days depending on group))
- Adverse events related to device use(From enrollment through the monitoring period, up to 45 days depending on study group)
Investigators
Fabio Biscegli Jatene
Full Professor of Cardiovascular Surgery at the University of São Paulo Medical School (FMUSP) and General Director of InCor-HCFMUSP
University of Sao Paulo