FAPO-2: Cardiac Patient Monitoring Tool for Clinical Observation and Arrhythmia Detection
Phase: NA
Conditions: Heart Diseases, Atrial Fibrillation (AF), Angina, Unstable
Sponsor: University of Sao Paulo

                                                                                                                       
 
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FAPO-2: Cardiac Patient Monitoring Tool for Clinical Observation and 
Arrhythmia Detection 
 
 
Funded by Samsung 
 
 
 
 
 
 
Pesquisadores: Prof. Dr. Fabio Biscegli Jatene 
Dra. Rosangela Monteiro 
Eng. Guilherme Rabello 
Dra. Camila Rodrigues Moreno 
Pietro Colonna 
Enf. Matheus Santos Moitinho 
Enf. Bruna Mendes Lopes 
Prof. Dr. Carlos Alberto Pastore 
Prof. Dr. Luiz Antônio Machado César 
Prof. Dr. Mauricio Ibrahim Scanavacca 
Prof. Dr. Alexandre Antônio Cunha Abizaid 
Eng. Dr. Fabio Antero Pires 
 
 

                                                                                                                       
 
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RESUME 
Wearable devices, such as smartwatches, have emerged as promising 
tools in digital health, with expanding clinical applications supported by recent 
scientific evidence. Studies have demonstrated positive impacts of these devices 
in cardiovascular medicine, including prevention, remote management of patients 
with chronic conditions, and arrhythmia screening, as observed in the FAPO-1 
study. This project aims to acquire health data through the remote monitoring of 
cardiac patients using the Galaxy Watch 6 Smartwatch, integrated with the 
Samsung Health and Samsung Health Monitor applications, and the Huinno™ 
MEMO Patch device for short-term electrocardiographic monitoring. 
The study will include 520 adult cardiac patients, stratified by sex (1:1), 
with a minimum age of 22 years and regular outpatient follow-up. The sample will 
be divided into four groups: a Pilot Group (n=15), composed of healthy 
volunteers for usability and functionality validation; the Extensive Outpatient 
Monitoring Group (n=150), monitored using the Galaxy Watch6 Smartwatch™ 
during the first 30±3 days, followed by 15±3 days using only the Huinno MEMO 
Patch (total monitoring time of 45±3 days); the Extensive Post-Intervention 
Monitoring Group (n=50), which includes patients who have recently undergone 
cardiovascular interventions, following the same monitoring protocol as the 
Extensive Outpatient Monitoring Group; and the Optimized Outpatient 
Monitoring Group (n=305), monitored for 15±3 days simultaneously using the 
Galaxy Watch6 Smartwatch™ (for heart rate and ECG collection) and the Huinno 
MEMO Patch for continuous ECG recording. 
This approach will allow not only for the robust collection of data for 
analysis, but also the evaluation of adherence, cost-effectiveness, and clinical 
efficiency across different telemonitoring protocols, contributing to significant 
advancements in cardiovascular practice. 
 
 

                                                                                                                       
 
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1. INTRODUCTION 
The global landscape of health monitoring is constantly evolving, driven 
by technological advancements. The accessibility and integration of smart 
technologies have gained prominence in response to the growing demand for 
scalable solutions. The widespread use of smartwatches and wearable 
technologies is evident, especially in monitoring, controlling, and modeling health 
processes, with a strong focus on the management of cardiovascular patients1,2. 
The increase in life expectancy in developed countries has motivated the 
advancement of these technologies, transforming perspectives on population 
aging. Awareness of the importance of preventive measures and healthy habits 
is growing, resulting from the intersection of progress in both medicine and 
technology3,4. In this context, the fitness & wellness movement plays a 
fundamental role, promoting a shift in healthcare where individuals become co-
responsible for their own well-being and health status5,6. 
The advancement of wearable devices, especially smartwatches, stands 
out as a promising avenue in digital health. Although still in its early stages, their 
use as clinical tools is gaining validity, supported by recent scientific evidence7,8,9. 
Rigorous studies have explored the impact of these devices in cardiovascular 
medicine, covering prevention, arrhythmia screening, and remote management 
of chronic cardiac patients, including those in the postoperative period, as 
demonstrated in the previous FAPO-1 study10,11,12. 
The integration of technological functionalities—such as accelerometers, 
photoplethysmography, and the ability to perform single-lead electrocardiograms 
(ECG)—allows for the reading of multiple clinical parameters, both quantitative 
and categorical. These data complement medical assessments, supporting 
clinical decision-making and enhancing the quality of healthcare delivered13,14.  
In addition, computational statistical methods like machine learning—
including supervised and semi-supervised approaches—are increasingly being 
used to capture and analyze health information. Machine learning, coupled with 
process automation, enables algorithmic learning for artificial intelligence 
applications in the detection and development of innovative digital health 
screening methods15. The use of these technologies as auxiliary tools promotes 
a paradigmatic shift in healthcare, offering new perspectives for clinical 

                                                                                                                       
 
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monitoring and follow-up regardless of the patient’s required technological 
complexity16,17. 
Cardiovascular care stands out in this scenario. Parameters such as heart 
rate (HR), blood pressure (BP), arterial oxygen saturation (SpO₂), and ECG, 
monitored by smartwatches, provide a comprehensive and accurate view of 
cardiac activity18,12. This modality overcomes the limitations of traditional clinical 
monitoring methods, especially due to the flexibility and opportunity afforded by 
continuous data recording15. 
Although wearable devices and their health applications independently 
offer valuable data, it is crucial to recognize their limitations in providing clinically 
detailed and individualized information19. To bridge this gap, a digital platform for 
health data management is essential20. This platform complements smartwatch 
readings by aggregating comprehensive information and facilitating evaluation by 
qualified healthcare professionals. In detecting cardiac arrhythmias—especially 
Atrial Fibrillation (AF)—smartwatches stand out as impactful screening tools for 
monitored patients, potentially resulting in clinically relevant benefits21. 
AF is the most prevalent arrhythmia in adults, affecting around 60 million 
people worldwide22. It is associated with serious complications, such as 
pulmonary embolism, stroke, and heart failure, making pragmatic monitoring 
essential to mitigate risks. By monitoring the electrocardiographic rhythm, early 
detection of AF onset or recurrence is possible, enabling appropriate medical 
interventions, 
including 
medication 
adjustments 
(anticoagulants 
and 
antiarrhythmics) and procedures to control heart rhythm23,24,25. Continuous or 
periodic monitoring supports treatment evaluation, allowing for the tracking of 
disease progression and adjustment of therapeutic strategies as needed26. 
Cardiac rhythm monitoring can benefit various profiles of patients with 
cardiovascular disease. Beyond the positive outcomes observed in the previous 
FAPO-1 project, which focused on monitoring post-surgical cardiovascular 
patients, it is clear that this approach should be extended to chronic cardiac 
patients and other cardiovascular profiles.  
Studies emphasize the high incidence of AF in patients with acute 
coronary syndrome, valvular disease, and those with pre-existing electrical 
conduction disorders27, due to structural dysfunctions that affect cardiac electrical 
function28. This includes chronic patients and those undergoing minimally 

                                                                                                                       
 
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invasive procedures such as percutaneous coronary intervention, transcatheter 
aortic valve implantation, and invasive electrophysiological procedures.  
Thus, patients with chronic heart conditions face ongoing challenges and 
are susceptible to complications requiring continuous care29. Continuous or 
periodic monitoring of AF in these patients is essential for early arrhythmia 
detection and appropriate therapeutic interventions, including the use of 
antiarrhythmic or anticoagulant medications, aiming to prevent serious adverse 
events30. 
In this context, electrocardiographic rhythm monitoring of chronic patients 
plays a key role by enabling early identification of AF presence or recurrence, 
and by acting as an important tool for tracking disease progression and identifying 
triggering factors31. Similarly, in patients undergoing minimally invasive 
procedures, procedural effects combined with the intrinsic structural arrhythmic 
substrate in various cardiovascular groups increase vulnerability to AF 
episodes32.  
To overcome challenges in traditional monitoring, the pursuit of 
technological innovations is fundamental. Studies highlight the importance of 
extending the monitoring period after procedures such as ablation for paroxysmal 
AF33. The use of smartwatches, due to their flexibility, allows for the capture of 
AF recurrences outside the intervals of traditional methods, resulting in improved 
diagnostic outcomes—even in asymptomatic patients34. 
In addition to measuring multiple health parameters, smartwatches stand 
out in remote telemonitoring by going beyond cardiac electrical conduction. The 
incorporation of these innovations into clinical settings has become more 
common and relevant due to their growing popularity in daily life. These devices 
hold great potential for continuous monitoring of heart rhythm and health 
parameters, allowing early detection of AF events or significant changes in vital 
signs. 
To manage and centralize patient monitoring, the FAPO-SI³ telemonitoring 
platform was developed as a result of the FAPO-1 study. It integrates with the 
Samsung Galaxy Watch 6 smartwatch and the Samsung Health Monitor and 
Samsung Health apps, enabling precise acquisition of health parameters. Its 
interface contributes to efficient organization and management of information, 

                                                                                                                       
 
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giving healthcare professionals a clear view of the data to identify patterns and 
deviations. 
The platform uses system components to store data on Amazon Web 
Services (AWS) cloud and in the Integrated Institutional Information System (SI³) 
at the InCor data center, ensuring secure handling and storage while maintaining 
the confidentiality and integrity of information. 
The essence of the method lies in the strategic application of Samsung 
Galaxy Watch 6 wearable devices, integrated with the Health Monitor and Health 
apps from Samsung, installed on Galaxy series smartphones. This convergence 
enables the collection of crucial biometric data such as blood pressure (BP), 
oxygen saturation (SpO₂), heart rate (HR), and enhanced detection of atrial 
fibrillation (AF) events through single-lead electrocardiograms (ECG). 
Additionally, the innovative approach includes the Huinno MEMO™ 
Patch device, intended for continuous ECG data collection (Figure 1). The 
Huinno™ MEMO Patch plays a critical role by establishing a gold standard for 
comparison with ECG data from the Samsung Galaxy Watch 6 Smartwatch. 
This addition enriches cardiovascular analysis by providing a continuous and 
detailed source of the heart’s electrical information. 
 
Figura 1. Huinno MEMOTM Patch Device. 
 
The innovation of this project lies in exploring the contribution of these data 
to care management and clinical decision-making. A key highlight is the 
advanced development of the artificial intelligence (AI) model, which serves as a 

                                                                                                                       
 
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central pillar. The proposal goes beyond optimizing health monitoring—it aims to 
efficiently prioritize patients based on the data collected by smartwatches. 
The complexity of the AI model lies in the detailed analysis of data, 
exploring correlations between various pathophysiological parameters. This 
approach seeks to create essential indicators, documented transparently to 
ensure the quality of the model. The goal is to consolidate an advanced AI 
strategy that enhances the identification of and response to critical health 
situations, representing a significant step forward in the use of technology for 
preventive cardiac care. 
The refinement of the remote care model, supported by simple and reliable 
devices, combined with a data management platform and advanced statistical 
models, aims not only to optimize efficiency but also to generate economic 
benefits by reducing unnecessary costs. This innovative approach sets a new 
standard in the application of technology, allowing for the anticipation of 
corrective measures, early identification of abnormal situations, and treatment 
optimization. The development of the AI model is, therefore, crucial to promoting 
more positive and transformative outcomes for patients undergoing clinical 
monitoring. 
2. OBJECTIVE 
 
2.1. Primary objective 
To develop a classification model using data from the Samsung™ Galaxy 
Watch6 Smartwatch and the Huinno™ MEMO Patch device, integrating them 
into the FAPO-SI³ Web platform to enable accurate patient stratification based 
on the severity of cardiac conditions, and to allow early detection of complications 
through continuous monitoring. 
 
2.2. Secondary objective 
To enhance the FAPO-SI³ Web telemonitoring platform by introducing 
advanced features for detailed visualization and analysis of trend curves and the 
integration of multiple health variables. Additionally, to integrate the Huinno™ 
MEMO Patch with the smartwatch for continuous ECG waveform capture, extract 

                                                                                                                       
 
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critical information such as heart rhythm fluctuations, and provide accurate 
management reports.. 
 
3. METHODS 
 
3.1 Devices 
3.1.1. Samsung Galaxy Watch 6 
The Samsung Galaxy Watch 6 devices are advanced wearables that 
integrate bioparameter monitoring technology with the functionalities of a 
smartwatch. Equipped with biosensors such as the BioActive sensor—which 
provides accurate readings of heart rate (HR), blood oxygen saturation (SpO₂), 
blood pressure (BP), and single-lead electrocardiogram (ECG)—these 
smartwatches are capable of continuously monitoring the user’s heart activity. 
The Galaxy Watch 6 also offers additional features such as physical activity 
tracking and sleep analysis. The data collected is synchronized with the Samsung 
Health and Samsung Health Monitor apps, allowing users to track their progress 
and receive personalized guidance to improve their cardiovascular and overall 
health. 
 
3.1.2. Smartphone  
A smartphone based on the Android operating system will be used in 
synchronized connection via Bluetooth with the Galaxy Watch 6 and the Huinno 
MEMOTM Patch to store and synchronize the data collected through the app 
installed on the smartphone, for the collection and transmission of biometric data. 
 
3.1.3. Huinno MEMOTM Patch 
The Huinno MEMOTM Patch is a cardiac monitoring device that employs 
integrated biometric sensors to continuously and non-invasively capture electrical 
cardiac activity. This device is attached using dermal adhesive electrodes, 
allowing for continuous monitoring of cardiac electrical activity for up to 14 

                                                                                                                       
 
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consecutive days. The data collected is stored in the device’s internal memory, 
enabling retrospective analysis. The HUINNO™ MEMO Patch is characterized 
by a discreet and comfortable design, ideal for prolonged use without interfering 
with the user’s daily activities. The HUINNO™ MEMO Patch is a product of 
Huinno Co., Ltd. of South Korea. Approximately 50 units of this device will be 
imported, as it can be reused with multiple patients after replacing the single-use 
disposable materials that come into direct contact with the participant's skin.  
 
3.2. Study location 
This project will be conducted entirely within the facilities of the Heart 
Institute (InCor) of the Hospital das Clínicas, Faculty of Medicine, University of 
São Paulo (FMUSP).  
 
3.3. Sample Composition 
The sample will consist of approximately 520 patients with chronic heart 
diseases under regular follow-up at the Heart Institute’s outpatient clinic. 
Participants will be divided into four groups: Pilot Group, Extensive Outpatient 
Monitoring Group, Extensive Post-Intervention Monitoring Group, and Optimized 
Outpatient Monitoring Group. The first group will consist of clinically healthy 
participants, and the second group of patients after minimally invasive 
cardiovascular intervention.  
 
● Group 1 – Pilot (n=15): Healthy volunteers without any history or prior 
diagnosis of arrhythmias or heart disease; 
 
● Group 2 – Extensive Outpatient Monitoring (N=150):  Patients with 
chronic heart conditions in regular outpatient care. Monitoring will be 
conducted using the Galaxy Watch6 Smartwatch™ during the first 30±3 
days, followed by 15±3 days with the Huinno™ MEMO Patch. The total 
monitoring period will be 45±3 days.   
 
● Group 3 – Extensive Post-Intervention Monitoring (N=50): Patients 
who have undergone interventional procedures such as angioplasty or 
valve implantation. Monitoring will be done using the Galaxy Watch6 

                                                                                                                       
 
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Smartwatch™ during the first 30±3 days, followed by 15±3 days with the 
Huinno™ MEMO Patch. Total monitoring: 45±3 days.   
 
● Group 4 – Optimized Outpatient Monitoring (n=305):  Stable patients 
with chronic heart conditions. For 14±3 days, patients will be 
simultaneously monitored with the Galaxy Watch6 Smartwatch™ (for 
heart rate and ECG data collection) and the Huinno MEMO Patch for 
continuous ECG recording. 
 
3.4. Inclusion criteria 
● Patients with heart disease, of both sexes, over 22 years old; 
● Consent to participate by signing the informed consent form (ICF); 
● Assentation to comply with study procedures and requirements; 
● Patients indicated for outpatient follow-up due to cardiovascular 
disease or for surgical or catheter-based interventions (e.g., 
arrhythmia ablation, transcatheter aortic valve implantation, 
angioplasty, etc.); 
● Low or no risk of skin injury based on the Braden Scale or clinical 
team’s judgment; 
 
3.5. Exclusion criteria 
● Presence of skin conditions such as vitiligo, lupus, or atopic 
dermatitis, as well as wrist tattoos that may interfere with the optical 
sensor of the smartwatch; 
● Sensitivity or history of allergic reactions to materials used in 
wearable devices (Samsung Galaxy Watch6 Smartwatch™ and 
Huinno MEMOTM Patch) or related items like adhesives and 
electrodes; 
● Inability to use the wearable monitoring devices properly due to 
physical, cognitive, or technological limitations; 

                                                                                                                       
 
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● Presence of peripherally inserted central catheter (PICC) or 
arteriovenous fistula; 
● Presence of implantable cardiac devices like pacemakers, 
defibrillators, or cardiac resynchronizers that prevent ECG 
acquisition via smartwatch; 
● Diagnosed conditions that cause narrowing or obstruction of the 
aorta or subclavian arteries (e.g., Stanford type A chronic aortic 
dissection, Takayasu’s disease, Subclavian Steal Syndrome, and 
Kawasaki disease), as these can affect pressure differences 
between upper limbs and influence assessments in the study; 
 
3.6. Study design 
Patients will be selected aiming for a 1:1 gender ratio in the sample 
composition. Special emphasis will be placed on ethnic diversity, expanding the 
inclusion of patients with Fitzpatrick skin types V and VI (Annex 8.2). The sample 
will also be enriched by including individuals with higher body mass index (BMI) 
and a broad age range, especially those over 40 years old, to reflect the 
demographic diversity of the target population. 
There is a special interest in including participants with paroxysmal 
(subclinical) atrial fibrillation (AF), as this condition plays a central role in the 
study’s objectives. Efforts will be made to select patients with a higher clinical risk 
for paroxysmal AF (particularly in the Outpatient Monitoring Group), despite it 
being subclinical and hard to detect. These representative traits are not strict 
inclusion criteria but will help enrich data quality and the comprehensiveness of 
the research database. The target is to include approximately 40 patients per 
month during the clinical execution phase. 
 
3.6.1. Pilot Phase 
➢ 
Selection of 15 healthy volunteers, without a history or prior 
diagnosis of arrhythmias or heart disease, all staff members of the Heart 
Institute (InCor/FMUSP); 

                                                                                                                       
 
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➢ 
The phase will last approximately 14±3 days, during which each 
volunteer will be remotely monitored using both the Huinno MEMOTM 
Patch and the Samsung Galaxy Watch6 Smartwatch™ in conjunction 
with the Samsung Health and Samsung Health Monitor apps; 
➢ 
 The objective of this phase is to evaluate potential adverse skin 
reactions to both devices and assess the flow and effectiveness of health 
data capture; 
➢ 
Observations and tests regarding the synchronization between 
devices and the FAPO-SI³ platform, together with the Samsung Health and 
Samsung Health Monitor apps; 
➢ 
Detailed study of the skin hygiene protocol and proper placement 
of the Huinno MEMO™ Patch; 
➢ 
Durability, adhesion, and allergic reaction testing of the Huinno 
MEMO™ Patch on healthy volunteers; 
➢ 
Use of the Braden Scale to assess the risk of pressure injury 35, and 
identification of medical adhesive–related skin injury (MARSI)36 caused by 
the Huinno MEMO™ Patch. 
 
3.6.2. Recruitment and Selection 
➢ Patients with chronic heart disease or those recruited after 
percutaneous cardiac intervention will be identified in the outpatient clinic 
at the Heart Institute, FMUSP, provided they meet the eligibility criteria 
and desired profile for study participation. 
 
3.6.3. Inclusion Outpatient Consultation 
➢ Patients selected for the Extensive Outpatient Monitoring Group 
(Group 2) (n=105) and the Optimized Outpatient Monitoring Group 
(Group 4) (n=305) will be invited to participate and will provide informed 
consent and commitment to the study. 
➢ Patients in the Extensive Post-Intervention Monitoring Group 
(Group 3) (n=50) will have a pre-hospitalization outpatient consultation. 

                                                                                                                       
 
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➢ Detailed information will be provided during the consultation 
regarding the study protocol, follow-up, teleconsultations, and device 
usage. 
➢ Patients in Groups 2 and 3 will initially receive instructions on how 
to use the Samsung Galaxy Watch6 Smartwatch™ for 30±3 days, for 
the collection of heart rate (HR), blood pressure (BP), oxygen saturation 
(SpO₂), and the angina feature (for coronary patients with angina). After 
this period, in the intermediate consultation, they will receive training on 
the Huinno MEMOTM Patch. 
➢ Patients in Group 4 will receive complete instructions during the 
initial consultation for using both devices (Samsung Galaxy Watch6 
Smartwatch™ and Huinno MEMO™ Patch), and will be trained to 
perform spot checks using the Samsung Health, Samsung Health 
Monitor apps, and other tools from the study. 
➢ Health data will be simultaneously collected by conventional 
methods and the Galaxy Watch6 Smartwatch™ at the time of device 
installation. 
 
3.6.4. Monitoring of Hospitalization for Interventional Procedures 
(Group 3) 
➢ The clinical team will follow the journey of patients eligible for the 
study. 
➢ Surgical waiting lists and procedures will be monitored, with the 
identification of post-intervention complications or events. 
➢ During the post-intervention period, unexpected events and 
recovery times will be recorded. 
➢ The institutional SI³ platform will be used to track the patient's 
clinical course, ensuring an ethical and humanized approach while 
respecting the recovery period. 
 
 
 

                                                                                                                       
 
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3.6.5. Intervention 
➢ Patients in Group 3 will undergo interventional procedures in the 
hemodynamics unit; 
➢ After the procedure, they will be transferred to the ICU, inpatient 
unit, or a specialized recovery area, according to clinical need; 
➢ During hospitalization, the clinical team will perform continuous 
evaluations to ensure patient stability. 
 
3.6.6. Post-Cardiac Intervention Evaluation (Group 3) 
➢ Patients who meet the inclusion criteria will be invited again to 
participate and provide informed consent. 
➢ During this phase, professionals will reinforce information about the 
clinical study, follow-up, teleconsultations, and use of the Samsung 
Smartwatch™ Galaxy Watch6 devices. 
➢ Patients will be trained to adjust the smartwatch, perform ECG, BP, 
HR, and SpO₂ readings, record symptoms, and complete well-being 
questionnaires. 
➢ Simultaneous acquisition of health data will be performed using 
conventional methods and the Samsung Smartwatch™ Galaxy Watch6 
at the time of device setup. 
 
3.6.7. Remote Monitoring and Assisted Monitoring by 
Teleconsultations (Groups 2, 3 and 4) 
➢ Patients will be remotely monitored for approximately 30±3 days 
using the Samsung Smartwatch™ Galaxy Watch6; 
➢ The devices will collect health data (HR, BP, SpO₂, ECG) via the 
Samsung Health and Samsung Health Monitor apps, while the FAPO-X 
system will be responsible for extracting and analyzing this information. 
➢ Patients will perform daily measurements (3x/day), record 
symptoms, and respond to questionnaires. 

                                                                                                                       
 
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➢ Remote follow-up will be carried out through teleconsultations, 
during which healthcare professionals will review collected data, ECG 
records (PDF), reported symptoms, and provide personalized guidance as 
needed.  
 
● ● Group 4 (Optimized Ambulatory Monitoring) 
➢ Patients in this group will be remotely monitored exclusively for 
heart rate (HR) through the FAPO SI³ platform. 
➢ The goal is to assess participant engagement, allowing a partial 
clinical assessment based on usage patterns. 
➢ If HR abnormalities or patient-reported symptoms are detected, 
teleconsultations will be scheduled for more detailed clinical evaluation. 
➢ If the smartwatch ECG shows abnormalities, the patient will be 
immediately called in for medical evaluation. 
 
3.6.8 In-Person Follow-up Consultation (Groups 2 and 3) 
➢ After 30±3 days, patients in Groups 2 and 3 must return to the 
institution for an in-person outpatient visit. 
➢ During this visit, the Huinno MEMO™ Patch will be allocated, along 
with instructions on: 
• Proper device usage 
• Daily electrode replacement 
• ECG acquisition using the Spotcheck app 
• Safe storage of the device until return at the final consultation 
 
➢ Healthcare professionals will assess patient progress, review 
collected data, perform physical exams, and discuss the individualized 
care plan. 

                                                                                                                       
 
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3.6.9. Survey Closure Query (All Groups) 
All participants, regardless of their group, will take part in a final visit 
at the end of the monitoring period. This visit aims to consolidate clinical 
and technological data collected during the study, assess the 
intervention's impact on patient health, and gather detailed feedback on 
the experience with the devices. 
During the visit, the following steps will be conducted: 
• 
Physiological Data Acquisition 
➢ 
Simultaneous collection of health parameters using both 
conventional methods and the SAMSUNG Smartwatch™ Galaxy Watch6, 
including: 
➢ 
ECG, blood pressure (BP), heart rate (HR), and peripheral oxygen 
saturation (SpO₂) – when applicable. 
➢ 
In cases where BP and SpO₂ measurement is not feasible, only HR 
and ECG will be recorded. 
• 
Data Extraction and Analysis 
➢ 
Complete transfer of data collected by the devices to the FAPO SI³ 
platform. 
➢ 
Review of accumulated records throughout monitoring, enabling 
comparative analysis with baseline data. 
• 
Comprehensive Clinical Evaluation 
➢ 
Detailed medical history and physical examination to assess the 
patient’s current health status. 
➢ 
Review of monitored parameters, correlating them with the patient's 
clinical conditions and observed outcomes. 
• 
Quality of Life and Satisfaction Questionnaires 
Standardized questionnaires will be administered to assess: 
➢ 
The impact of remote monitoring on patients' health perception and 
quality of life. 

                                                                                                                       
 
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➢ 
Adherence level to the study, main challenges encountered, and 
device usability. 
➢ 
Overall impressions regarding the technology used in the study. 
• 
Post-Study Care Planning and Discussion 
➢ 
Healthcare professionals will assess patient progress over the 
monitoring period and record an individualized care plan, if needed. 
➢ 
Personalized guidance will be provided based on clinical findings 
and the patient's reported experience. 
➢ 
At the end of the visit, a structured perception and satisfaction 
questionnaire regarding device use (Appendix 8.4) will be administered, 
enabling a comprehensive evaluation of technology acceptance and 
impact within the study. 
 
 

                                                                                                                       
 
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Figure 2. Conceptual diagram of the patient journey flow and data collection for the FAPO-2 
study. 
 
3.7. Anamnese completa 
After confirming participation in the study, initial clinical assessments will 
be scheduled. Volunteers will undergo an evaluation of their personal and family 
health history, with the variables to be collected detailed in the study’s Case 
Report Form (CRF) (Appendix 8.1). In addition, through questionnaires, data 
will be collected regarding health status, technological perception, and events 
observed during the remote monitoring phase, covering aspects such as health 
parameters, symptoms presented, medication use, among others. 
 
3.8. Provision and use of devices 
 
Participants in the ambulatory monitoring group will receive Samsung 
devices, such as smartphones, the Samsung Galaxy™ Watch6 smartwatch, and 
the Huinno Memo™ Patch, during the inclusion consultation. For the post-
intervention monitoring group, participants will receive the devices one hour prior 
to the cardiovascular procedure. Participants will sign a loan liability agreement, 
committing to return the devices and assuming full responsibility for any damage, 
as detailed in Appendix 8.5. 
Data collection will occur over 45±3 days or 15±3 days, with remote follow-
up by the team. During the first 14 days, participants will use both the Huinno 
Memo™ Patch and the Samsung Galaxy™ Watch6 smartwatch; after this period, 
monitoring will continue exclusively with the smartwatch. Smartphones and 
smartwatches, using the Samsung Health and Samsung Health Monitor apps, 
will track HR, BP, SpO₂, and episodes of cardiac arrhythmias (ECG). The Huinno 
Memo™ Patch will continuously capture ECG for comparative analysis as part of 
the study outcomes. 
All devices will be delivered with pre-installed apps and personalized by 
the Innovation team. Data will be collected via an embedded application. 
Participants will return the equipment at the final study visit at InCor. 

                                                                                                                       
 
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3.9. 
Traditional 
Electrocardiography 
(ECG) 
vs 
SAMSUNG 
smartwatch ECG 
Resting ECG exams will be conducted, and ECGs collected via the 
Samsung Galaxy™ Watch6 smartwatch to compare standard analysis methods 
and the device. Gold-standard ECGs will be performed when applying the device, 
either during the ambulatory visit (ambulatory monitoring group) or one hour 
before the intervention (post-intervention group), and at the final visit after 45±3 
or 15±3 days of monitoring. 
All ECGs will be recorded at a speed of 25 mm/sec, calibrated at 
1mV/10mm, using the MAC 2000 ECG Machine in an outpatient setting. 
Electrodes will follow the classic 12-lead configuration. ECGs will be 
simultaneously recorded by the smartwatch and standard method, allowing for 
concordance, equivalence, sensitivity, and specificity analyses at the end of the 
study. Parameters will be assessed by a cardiologist according to the Brazilian 
Society of Cardiology guidelines. 
The smartwatch’s intermittent ECG data collection aims to better 
understand the patient's profile and support machine learning models related to 
patient severity. Evaluating the concordance, sensitivity, and specificity of data 
from both standard and smartwatch methods ensures robustness for developing 
the severity prediction model. 
 
3.10. Measurement of peripheral oxygen saturation by SAMSUNG 
smartwatch versus standard oximetry 
SpO₂ levels will be measured simultaneously using the Samsung 
Galaxy™ Watch6 smartwatch and the Fingertip-Bewine® digital oximeter during 
ambulatory consultations (ambulatory monitoring group) and one hour prior to 
interventions (post-intervention group). During the 45±3 or 15±3 day remote 
monitoring phase, continuous SpO₂ data will be collected exclusively via the 
Samsung Galaxy™ Watch6 smartwatch, with participants instructed to take 
readings three times daily or as prompted by the app. In case of unsuccessful 
attempts, up to 10 additional attempts will be allowed. If readings cannot be 
obtained, participants will be asked to wear the smartwatch overnight to measure 
saturation during sleep. 

                                                                                                                       
 
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This continuous data collection aims to understand patient profiles and 
capture key parameters for machine learning models related to severity, 
monitoring health status over time. Data from both standard and smartwatch 
methods will be used to evaluate concordance, sensitivity, and specificity, 
ensuring robustness for the proposed severity model. 
 
3.11. Blood pressure (BP) measurement by SAMSUNG smartwatch 
versus standard device 
Calibration of the SAMSUNG Galaxy Watch6 smartwatch for BP 
measurement will be performed during device placement, either at the outpatient 
consultation (Extensive Ambulatory Monitoring Group) or one hour before the 
intervention (Extensive Post-Intervention Monitoring Group). After calibration per 
device instructions, three consecutive resting measurements will be performed, 
alternating between the smartwatch and a standard arm sphygmomanometer 
(Welch brand). 
During the study’s remote monitoring phase (45±3 or 15±3 days), 
intermittent BP data will be collected exclusively using the Samsung Galaxy™ 
Watch6 smartwatch. Participants will be instructed to take BP readings three 
times daily or as indicated by the embedded app. This will allow for detailed 
comparison between the two methods (systolic and diastolic BP), evaluating 
concordance, equivalence, sensitivity, and specificity. 
The intermittent data collection aims to understand patient profiles and 
capture essential health parameters for machine learning models related to 
severity, in addition to monitoring changes in participants’ health over time. The 
evaluation of data from both methods ensures robustness for the development of 
the proposed severity model. 
 
 

                                                                                                                       
 
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3.12. FAPO SI³ Platform Enhancement and Health Alerts 
Enhancements to the FAPO SI³ platform and health alerts, under the 
FAPO-2 project, aim to optimize remote monitoring. Initially developed in the 
previous FAPO-1 project, the platform captured vital health data from the 
SAMSUNG Galaxy smartwatch, using a specific Android API to extract 
information from Samsung Health® and Health Monitor® apps. Data were stored 
in a PostgreSQL database hosted on an AWS EC2 instance and integrated into 
InCor’s Electronic Health Record (EHR), allowing the clinical team to view data 
from remotely monitored patients, with alerts for specific variables (Figure 3, 
Table 1).  
 
 
 
 
Figure 3. Description of the flowchart for capturing, storing, and managing the study's raw health 
data. Amazon Web Services (AWS) and EHR SI³ (InCor's Institutional Electronic Health Record). 
 
 
 

                                                                                                                       
 
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Table 1. Alert for Parameters Recorded by Smartwatch 
Blood Pressure 
Normal Range  
Systolic [100 – 140 
mmHg] and Diastolic [70-
90 mmHg]  
Yellow Alert 
Systolic [100 – 180 
mmHg] and Diastolic [90 
– 110 mmHg]  
Red Alert 
Systolic [<90 and >180 
mmHg] and Diastolic [<60 
mmHg and >100 mmHg]. 
Heart Rate 
Normal Range 
60–100 bpm.  
 
Red Alert 
HR <50 bpm outside 
sleep period; HR >100 
bpm (evaluated 
concurrently by the watch) 
Oxygen Saturation 
Normal Range  
95 – 100%  
Yellow Alert 
91 – 95%  
Red Alert 
<90%  
Table 1. Clinical alerts received through the FAPO-SI³ Web telemonitoring platform. 
No atual projeto, FAPO-2, estão previstas melhorias significativas, 
incluindo: 
➢ Improved Data Extraction: Optimization of the data extractor (FAPO-X 
App) to ensure more efficient and comprehensive capture of relevant 
health information. 
➢ Development of Dynamic Trend Curves: Advanced visualization of 
health parameters to better understand interrelationships between 
variables. 
➢ Improvement of the Clinical Records Module: Efficient synchronization 
of medical and prescription data with InCor’s EHR to optimize real-time 
clinical decision-making. 

                                                                                                                       
 
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➢ Patient Classification Based on Theoretical Criteria: Group-based 
classification for personalized healthcare approaches. 
➢ Efficient Alerts and Communication: Health alerts based on pre-
established limits will be sent to the multidisciplinary team, promoting early 
detection of complications. 
➢ Detailed Reporting and Efficient Monitoring: Implementation of reports 
including metrics such as number of active patients, critical alerts, and 
resolution time, supporting future scalability evaluation. 
 
These parameters will be incorporated into the platform’s system, as illustrated 
in the hypothetical dashboard in Figure 4. 
 
Figure 4. Hypothetical illustrative example of improved control panels proposed as an 
improvement for the FAPO-SI³ Web platform. 
 
3.13. Advanced Development of Artificial Intelligence Model for 
Prioritization and Monitoring through Smartwatch 
As part of the project, the development of the Artificial Intelligence (AI) 
model plays a crucial role in prioritizing patients based on data captured by the 
smartwatch, aiming to optimize health monitoring. The core of the prioritization 
model focuses on the creation of a classification algorithm capable of alerting to 
deviations from reference standards and deteriorations in health parameters. 

                                                                                                                       
 
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Simultaneously, this clinical study provides essential data for building a robust 
database. The analysis of the collected data will explore correlations between 
different pathophysiological parameters, resulting in the creation of indicators for 
prioritization. This detailed approach will be documented to ensure quality 
analysis of the model, consolidating an advanced AI strategy that enhances the 
capacity to identify and respond to critical health situations, significantly 
contributing to innovation in the care of cardiac patients at varying levels of 
complexity and severity. 
 
4. ETHICAL ASPECTS 
The principal investigator will ensure that the Informed Consent Form (ICF 
– Annex X) is obtained in accordance with international regulatory specifications 
and requirements of the ICH (International Council for Harmonisation of 
Technical Requirements for Pharmaceuticals for Human Use), following the 
ethical principles established by the National Health Council Resolution (CNS, 
Resolution No. 466/2012). 
This study will be submitted for review by the CAPPesq Research Ethics 
Committee via the Plataforma Brasil, considering the ethical aspects involved in 
research with human subjects, as set forth in Resolution No. 466/2012. All data 
collected from volunteers will be treated with guaranteed confidentiality, in 
compliance with the requirements of the LGPD (Brazilian General Data 
Protection Law). 
Patient monitoring will be conducted by the multidisciplinary team through 
the SI³ system, allowing the detection of intercurrences in near real time, with 
immediate interventions and guidance for patients. After the conclusion of the 
study, the data will be anonymized and analyzed by the InCor team, and will be 
made available to the contracting company without any patient identification. 
Subsequently, the results will be published in scientific journals. During the 
development and refinement of the AI model, data will be shared by InovaInCor 

                                                                                                                       
 
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with the Viva Bem Laboratory in a fully anonymized manner, ensuring the privacy 
and confidentiality of clinical study participants. 
5. DATABASE 
The data generated in this study will be processed and anonymized in 
accordance with CNS Resolution 466/12 and the General Data Protection Law 
(Law No. 13.709/2018), with the principal investigator designated as the data 
controller. All data collected for this study will remain under the responsibility of 
InCor for at least five (5) years after the study's completion. 
The database to be established for the operation of this study will undergo 
rigorous anonymization in accordance with the aforementioned regulations. 
Initially, all direct identifiers such as full names, dates of birth, addresses, phone 
numbers, emails, and identification documents such as IDs or institutional 
registration numbers will be removed from the final database. Full names will be 
replaced by a randomly generated alphanumeric code, and dates of birth will be 
generalized to the year only. 
The data controller (principal investigator) will use codes to replace 
identifiable information. These codes will be stored separately from any 
identifiable data, ensuring the security and privacy of participants. Strict access 
control protocols will be established to safeguard anonymized data, allowing 
access only to authorized researchers. 
The anonymized database established in this study may be shared by the 
sponsor with other units of the global Samsung group (affiliates, subsidiaries, 
parent or controlled companies, including strategic partners both in Brazil and 
abroad), with the purpose of being used in the future for the development and 
improvement of algorithms, research, and scientific publications by the Samsung 
group, not necessarily related to this specific research. This data sharing will be 
limited to aggregated data analysis without the possibility of individual 
identification, and does not characterize the partners as co-participating centers 
in this research project.  
 
 
 

                                                                                                                       
 
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6. SCHEDULE 
 
 
 
Activity 
Month 
Bim 
1 
Bim 
2 
Bim 
3 
Bim 
4 
Bim 
5 
Bim 
6 
Bim 
7 
Bim 
8 
Bim 
9 
Bim 
10 
Bim 
11 
Project writing and 
submission to the 
Research Ethics 
Committee (CEP) and 
Plataforma Brasil 
1-2 
X 
 
Definition of statistical 
models 
1-2 
X 
 
Software development and 
maintenance cycles 
3-16 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
  
Study registration and 
follow-up on Clinical Trials 
4-6 
X 
X 
 
AI classification model 
development cycles 
3-23 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Patient selection and 
recruitment 
6-15 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Inclusion consultation and 
patient guidance 
6-15 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Data entry in the clinical 
data collection platform 
(REDCap) 
6-21 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Patient training planning 
and delivery 
5-15 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Hospitalization monitoring 
for interventional 
procedures 
6-20 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Post-intervention clinical 
assessment 
6-20 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Remote monitoring of 
patients and collected data 
for risk identification 
6-21 
X 
X 
X 
X 
X 
X 
X 
X 
X 
In-person outpatient visit 
45 days after the start of 
telemonitoring (study 
inclusion) for evaluation 
7-21 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Data analysis 
16-19 
 
X 
Preparation of technical-
scientific reports and 
articles for publication 
16-19 
 
X 

                                                                                                                       
 
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8. ANEXOS 
8.1. Case Report Form (CRF) 
CASE REPORT FORM 
Ferramenta de Acompanhamento de Pacientes 
cardíacos para Observação clínica e Detecção de Arritmias 
 
Estudo Samsung FAPO-2 
 
 
 
CLINICAL TRIAL/UNIDADE: INOVA InCor 
INVESTIGADOR PRINCIPAL: Dr. Fábio Biscegli Jatene 
INVESTIGADOR EXECUTANTE: Dr. _________________________ 
 
 
 

                                                                                                                       
 
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I am confident that the information provided in this case registration form is complete 
and accurate. I confirm that the study was conducted in accordance with the protocol 
and any amendments to the protocol, and that written informed consent was obtained 
prior to the study. 
 
Investigator’s Signature: 
 
 
 
Patient Name  
 
 
_____________________________________________________ 
 
 
 
Patient's Name: ---------------------------------------------------------------------------------------------------- 
 
 
 
 
Date of Signature: 
 
 
 
 
 
 
 
 
 
 
 
d 
d 
m 
m 
 
a 
a 
a 
a 
 
 
  
 

                                                                                                                       
 
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Critério de inclusão 
 
Sim 
 
Não 
1 
Is the patient over 22 years of age and has a cardiac condition 
 
 
 
 
 
 
 
 
2 
Did the patient voluntarily give written informed consent? 
 
 
 
 
 
 
 
 
3 
Is the patient willing to participate in remote monitoring for 
approximately 45±3 days or 15±3 days? 
 
 
 
 
 
 
 
 
4 
Does the patient agree to periodically replace the Huinno MEMOTM 
electrodes over a 14-day period?  
 
 
 
 
 
 
 
 
5 
Does the patient require outpatient follow-up for a cardiovascular 
disease or have indications for surgical or catheter-based intervention 
(e.g., ablation for arrhythmias, transcatheter aortic valve implantation, 
angioplasty)? 
 
 
 
 
 
 
 
 
6 
Does the patient have low or no risk for skin injury based on the Braden 
scale or clinical judgment? 
 
 
 
 
 
 
Critério de exclusão 
 
Sim*  
Não 
1  Does the patient have skin diseases (e.g., vitiligo, lupus, atopic 
dermatitis) or wrist tattoos that may interfere with optical sensor 
readings? 
 
 
 
 
 
 
 
 
2 
Does the patient have a known sensitivity or history of allergic reactions 
to wearable device components (e.g., Samsung GalaxyTM Watch6 and 
Huinno MEMOTM patch) or related items like adhesives and 
electrodes? 
 
 
 
 
 
 
 
 
3 
Does the patient have any physical, cognitive, or technological 
limitations that prevent proper use of wearable monitoring devices? 
 
 
 
 
 
 
 
 
4 
Does the patient have a PICC (Peripherally Inserted Central Catheter) 
or arteriovenous fistula? 
 
 
 
 
 
 
 
 

                                                                                                                       
 
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* If any inclusion criterion is marked as No, or any exclusion criterion is marked as Yes, 
the patient is not eligible for the study. 
     
VISITE 1 (SCREENING) 
 Date:  _______________ 
 
 
 
 
 
 
 
 
 
     DD MM AAAA 
DEMOGRAPHIC DATA  
 
Name: _______________________________________________________ 
Hospital Record: __________________ 
 
Age (years): 
 
 
 
Sex: 
Female  
Male  
 
 
 
Follow-up: (     ) 15 days    (     ) 45 days     
Height (m): 
 
●  
 
 
 
 
 
 
Weight (Kg): 
 
 
●  
 
 
 
 
 
BMI (BMI = Weight ÷ (Height × Height)): 
 
 
●  
 
 
 
 
5 
Does the patient have a cardiac implantable device (e.g., pacemaker, 
defibrillator, resynchronizer) that prevents ECG acquisition via 
smartwatch? 
 
 
 
 
 
 
 
 
6 
Does the patient have a diagnosis of conditions that cause narrowing or 
obstruction of the aorta or subclavian arteries? 
 
 
 

                                                                                                                       
 
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Ethnicity: _________________ 
 
Fitzpatrick Skin Type Scale:   
I: (   );   II: (   );   III: (   );   IV: (   );   V: (   );   VI: (   ); 
 
Sociodemographic Data:  
Education Level:  
No schooling: (   );   Incomplete primary education: (   );   Complete primary education: (   );    
Incomplete secondary education: (   );   Complete secondary education: (   );   Incomplete high 
school: (   );   Complete high school: (   );   Incomplete higher education: (   );   Complete higher 
education: (   );   Information not available: (   ); 
Marital Status: (    ) Single  (    ) Domestic Pathernship (    ) Married    
(    ) Divorced   (    ) Widowed 
Has a caregiver? (    ) Yes, lives together (    ) Yes, does not live together  (    ) No  
Household Income:  (    ) 2 wages (    ) 2 - 4 wages (    ) 4 - 10 wages (    ) > 10 wages  
 
CLINICAL ASSESSMENT: 
 
Chronic Heart Disease Diagnosis: 
(   ) Coronary Artery Disease   (   ) Heart Failure  (    ) Hypertension 
(   ) Cardiac Arrhythmias  (    ) Valvular Heart Disease    (    ) Cardiomyopathies 
(   ) Peripheral Vascular Disease   (    ) Cerebrovascular Disease 
(   ) Deep Vein Thrombosis / Pulmonary Embolism   (    ) Endocarditis 
(   ) Acute Coronary Syndrome 
 
 

                                                                                                                       
 
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Pre-intervention Disorder: 
(   )  Persistent AF or AF not responding to medication  (     ) Supraventricular Tachycardias 
(   )  Atrial Tachycardia  (    ) Aortic stenosis with high surgical risk 
(   ) Unstable Angina (    ) AMI   (    ) Coronary Artery Stenosis  (    ) AF associated with stroke 
risk 
 
Other, specify 
------------------------------------------------------------- 
Length of Stay:______________ 
 
Paroxysmal Atrial Fibrillation Present: (      ) Yes   (     ) No 
 
Type of Intervention Performed:  
(     ) Cardiac Surgery (CABG, valve, or combined) (    ) Cardiac Ablation (    ) Transcatheter 
Aortic Valve Implantation  (    ) Angioplasty   
 
Other, specify 
 ---------------------------------------------------------- 
 
 
CONSUMO  
Smoker or Former Smoke:  
(    ) Yes    (    ) No  
Use History:  
(   ) Current (Used for at least 6 months) 
(    ) Past (Used at some point, no use for over 6 months) 
Quantity: ___________________ 
 

                                                                                                                       
 
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Alcohol User or Former Alcohol User:  
(    ) Yes    (    ) No  
Use History:  
(   ) Current (Used for at least 6 months) 
(    ) Past (No use for over 6 months) 
Quantity: ___________________ 
 
Alcohol use includes reports or records of alcohol consumption, alcoholism, or intoxication. 
According to the WHO, acceptable weekly consumption is up to 15 units/week for men and 10 
units/week for women 
 
Illicit Drug Use:  
(    ) Yes    (    ) No  
Histórico de consumo:  
(   ) Current (Used for at least 6 months) 
(    ) Past (No use for over 6 months) 
Quantity: ___________________ 
 
CHARLSON COMORBIDITIES: 
(    ) Previous Myocardial Infarction (    ) Heart Failure 
(    ) Peripheral Arterial Disease (    ) Cerebrovascular Disease   
(    ) Dementia  (    ) Chronic Lung Disease 
(    ) Connective Tissue Diseases  (    )  Peptic Ulcer Disease 
(    ) Mild Liver Disease  (    ) Diabetes (without complications)  
(    ) Diabetes (with organ damage) (    ) Hemiplegia   
(    ) Moderate/Severe Renal Disease 
(    )  Solid Tumor (    )  Leukemia  (    )  Lymphoma / Multiple Myeloma 
(    ) Moderate/Severe Liver Disease (    )  Metastatic Solid Tumor 
(    ) AIDS 
(    ) None 

                                                                                                                       
 
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(    ) Hypertension (    )  Simple Dyslipidemia (    )  Mixed Dyslipidemia 
 
PHYSICAL ACTIVITY: 
 
 
       Yes 
 
       No 
 
 
If yes, activity intensity: 
( ) Light – breathes easily 
( ) Moderate – can converse 
( ) Vigorous – short of breath but can speak a few phrases 
( ) Strong – can speak one word at a time 
( ) Intense – breathless, cannot speak 
Type of Exercise Practiced: 
------------------------------------------------- 
Frequency per Week: ___________________ 
Hours per Day: _________________ 
 
MEDICATION USE 
Has the subject used any medication continuously or in the past 3 months? 
 
       Yes 
 
       No 
 
 
Medication Classes Used? 
( ) Antihypertensives 
( ) Antiarrhythmics 
( ) Antianginals 
( ) Anticoagulants 
( ) Antidiabetics 
 Outros: __________________________ 

                                                                                                                       
 
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If using antiarrhythmics:  
Medication Name: _________________ Dosage: _____________/____ times per day 
   
STUDY INCLUSION VISIT ASSESSMENT 
VITAL SIGNS 
Heart Rate – Standard 
(sitting) 
 
 
 
Bpm 
 
Heart Rate – 
Smartwatch (sitting) 
 
 
 
Bpm 
 
Blood Pressure – 
Standard (sitting) 
 
 
 
/ 
 
 
 
mmHg 
 
 
 
 
 
 
 
 
 
 
 
 
Blood Pressure – 
Smartwatch (sitting) 
 
 
 
/ 
 
 
 
mmHg 
 
 
SpO₂ – Standard 
(sitting) 
 
 
 
% 
 
SpO₂ – Smartwatch 
(sitting) 
 
 
 
% 
 
 
 
ECG – 12-LEAD 

                                                                                                                       
 
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Normal 
 
           Abnormal   
** 
**Observation: 
____________________________________________________________ 
 
( ) Sinus Rhythm ( ) Atrial Fibrillation 
( ) Atrial Flutter ( ) Atrial Tachycardia 
( ) Wide QRS Tachycardias ( ) Bradyarrhythmias 
( ) Sinus with Extrasystole ( ) AF with Extrasystole 
 
** Clinical Interpretation: (   ) Sinus  (    ) FA     (     ) Other 
 
ECG - Smartwatch 
 
Normal 
 
           Abnormal   
** 
**Observation: 
____________________________________________________________ 
 
( ) Sinus ( ) Atrial Fibrillation ( ) Atrial Flutter ( ) Atrial Tachycardias ( ) Wide QRS Tachycardias ( ) 
Bradyarrhythmias ( ) Sinus with Extrasystole ( ) Atrial Fibrillation with Extrasystole 
 
Medical Report: ( ) Sinus ( ) AF ( ) Others ( ) Insufficient Recording 
 
Smartwatch Report: ( ) Sinus ( ) AF ( ) Inconclusive ( ) Insufficient Recording 
   
CLOSING VISIT EVALUATION IN THE STUDY 
 
HEALTH PARAMETERS 
Heart Rate – Standard 
(seated) 
 
 
 
Bpm 
 
Heart Rate – 
Smartwatch (seated) 
 
 
 
Bpm 

                                                                                                                       
 
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Blood Pressure – 
Standard (seated): 
 
 
 
/ 
 
 
 
mmHg 
 
 
 
 
 
 
 
 
 
 
 
 
Blood Pressure – 
Smartwatch (seated): 
 
 
 
/ 
 
 
 
mmHg 
 
 
SpO₂ – Standard 
(seated): 
 
 
 
% 
 
SpO₂ – Smartwatch 
(seated): 
 
 
 
% 
 
 
 
 
 
    
ECG – 12-Lead 
 
Normal 
 
           ABnormal  
** 
**Observations: 
____________________________________________________________ 
 
( ) Sinus ( ) Atrial Fibrillation ( ) Atrial Flutter ( ) Atrial Tachycardias ( ) Wide QRS Tachycardias ( ) 
Bradyarrhythmias ( ) Sinus with Extrasystole ( ) Atrial Fibrillation with Extrasystole 
 
**Clinical Report: ( ) Sinus ( ) AF ( ) Others 
 
ECG - Smartwatch 
 
Normal 
 
           Abnormal   
** 

                                                                                                                       
 
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**Observations: 
____________________________________________________________ 
 
( ) Sinus ( ) Atrial Fibrillation ( ) Atrial Flutter ( ) Atrial Tachycardias ( ) Wide QRS Tachycardias ( ) 
Bradyarrhythmias ( ) Sinus with Extrasystole ( ) Atrial Fibrillation with Extrasystole 
 
Medical Report: ( ) Sinus ( ) AF ( ) Others ( ) Insufficient Recording 
 
Smartwatch Report: ( ) Sinus ( ) AF ( ) Inconclusive ( ) Insufficient Recording 
  
LABORATORY ANALYSES 
 
Initial 
 
 
 
Blood for hematology and biochemistry 
Collected by  
 
✔ 
 
Collection Date (dd mmm aaaa) 
 
 
Red Blood Cells  (milhões/mm³) 
 
 
 
 
 
 
 
 
 
 
 
 
Hematocrit (%) 
 
 
 
 
 
 
 
 
 
 
 
 
 
Hemoglobin (g/dL) 
 
 
 
 
 
 
 
 
 
 
 
 
 
MCV  (fl) 
 
 
 
 
 
 
 
 
 
 
 
 
 
MCH (pg) 
 
 
 
 
 
 
 
 
 
 
 
 
 
MCH Concentration (g/dl) 
 
 
 
 
 
 
 
 
 
 
 
 
 
Platelets (mm³) 
 
 
 
 
 
 
 
 
 
 
 
 
 
CRP (mg/L) 
 
 
 
 
 
 
 
 
 
 
 
 
 
BNP 
 
 
 
 
 
 
 
 
 
 
 
 
 
Troponin 
 
 
 
 
 
 
 
 
 
 
 
 
 
HDL 
 
 
 
 
 
 
 
 
 
 
 
 

                                                                                                                       
 
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LDL 
 
 
 
 
 
 
 
 
 
 
 
 
 
Triglycerides 
 
 
 
 
 
 
 
 
 
 
 
 
 
Albumin (g/dL) 
 
 
 
 
 
 
 
 
 
 
 
 
 
Glucose (mg/dL) 
 
 
 
 
 
 
 
 
 
 
 
 
 
Glycated Hemoglobin (%) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

                                                                                                                       
 
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STUDY CLOSURE FORM 
Please insert a copy of all results in the plastic sleeve at the back of the CRF. 
 
 
 
Reason for Study Termination (Please check only the primary reason. Any reason other than 
Study Completed requires explanation beside the answer.) 
☐ Study Completed 
☐ Adverse Event/Serious Adverse Event (complete the Adverse Event Form, if applicable): 
_________________________________________________________ 
☐ Lost to Follow-Up: _________________________________________________________ 
☐ Participant Not Eligible: 
_________________________________________________________ 
☐ Concomitant Medication: 
_________________________________________________________ 
☐ Contraindicated Medication: 
_________________________________________________________ 
☐ Withdrawal of Consent: 
_________________________________________________________ 
☐ Death: _________________________________________________________ 
☐ Other: _________________________________________________________ 

                                                                                                                       
 
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8.2. Escala Fitzpatrick 
 1a) What is your eye color? 
( ) Light blue, light gray, or light green 
( ) Blue, gray, or green 
( ) Hazel or light brown 
( ) Dark brown 
( ) Brownish black 
 
2a) What is your natural hair color? 
( ) Red or light blond 
( ) Blond 
( ) Dark blond or light brown 
( ) Dark brown 
( ) Black 
 
3a) What is your natural skin color (before sun exposure)? 
( ) Ivory white 
( ) Fair or pale 
( ) Fair to beige with golden undertone 
( ) Light brown or olive 
( ) Dark brown or black 
 
4a) How many freckles are there on unexposed areas of your skin? 
( ) Many 
( ) Quite a few 
( ) Some 

                                                                                                                       
 
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( ) Few 
( ) None 
 
Reaction to prolonged sun exposure 
 
1b) How does your skin react to the sun? 
( ) Always burns, blisters, and peels 
( ) Frequently burns, blisters, and peels 
( ) Burns moderately 
( ) Rarely burns, if at all 
( ) Never burns 
 
2b) Does your skin tan? 
( ) Never 
( ) Rarely 
( ) Sometimes 
( ) Often 
( ) Always 
 
3b) How deeply do you tan? 
( ) Not at all or very little 
( ) Lightly 
( ) Moderately 
( ) Deeply 
( ) Naturally dark skin 
 

                                                                                                                       
 
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4b) How sensitive is your face to the sun? 
( ) Very sensitive 
( ) Sensitive 
( ) Normal 
( ) Resistant 
( ) Very resistant / Never had any issues 
 
 

                                                                                                                       
 
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8.3. Mobile Device Proficiency Questionnaire (MDPQ) 

                                                                                                                       
 
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8.4. Fapo-2 User Experience Questionnaire 
 
1. How was your experience using the Galaxy Watch 6 to monitor your health? 
● Very unsatisfactory 
● Unsatisfactory 
● Neither satisfactory nor unsatisfactory 
● Satisfactory 
● Very satisfactory 
 
2. In one or two words, how would you describe your experience with the watch? 
_______________________________, _______________________________ 
 
3. How was your experience using the MEMO Patch device to monitor your heart 
rhythm? 
● Very unsatisfactory 
● Unsatisfactory 
● Neither satisfactory nor unsatisfactory 
● Satisfactory 
● Very satisfactory 
 
4. In one or two words, how would you describe your experience with the MEMO 
Patch? 
_______________________________, _______________________________ 
 
5. Would you continue using or use the smartwatch again after the home monitoring 
period? 
● Yes, definitely 
● Yes, probably 
● Not sure 
● No, probably not 
● No, definitely not 
 

                                                                                                                       
 
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6. Would you continue using or use the MEMO Patch again after the home monitoring 
period? 
● Yes, definitely 
● Yes, probably 
● Not sure 
● No, probably not 
● No, definitely not 
 
7. Compared to a traditional Holter monitor, how would you rate the MEMO Patch? 
● Much worse 
● Worse 
● Similar 
● Better 
● Much better 
● I have no experience with a traditional Holter monitor 
 
8. How was your overall experience using the phone and the app associated with the 
devices? 
● Very unsatisfactory 
● Unsatisfactory 
● Neither satisfactory nor unsatisfactory 
● Satisfactory 
● Very satisfactory 
 
9. How would you rate the ease of using the watch during the home monitoring period? 
● Very easy 
● Easy 
● Neither easy nor difficult 
● Difficult 
● Very difficult 
 

                                                                                                                       
 
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10. How did you feel wearing the watch in your daily routine? Was it comfortable for 
long periods? 
● Very comfortable 
● Comfortable 
● Moderately comfortable 
● Uncomfortable 
● Very uncomfortable 
 
11. How did you feel wearing the MEMO Patch in your daily routine? Was it 
comfortable for long periods? 
● Very comfortable 
● Comfortable 
● Moderately comfortable 
● Uncomfortable 
● Very uncomfortable 
 
12. Did you experience any discomfort or issues while using the watch? Please 
describe briefly: 
 
13. Did you experience any discomfort or issues while using the MEMO Patch? Please 
describe briefly: 
 
14. Would you recommend the use of the watch to others with similar needs? 
● Definitely not 
● Probably not 
● Neutral 
● Probably yes 
● Definitely yes 
 
15. Would you recommend the use of the MEMO Patch to others with similar needs? 
● Definitely not 
● Probably not 

                                                                                                                       
 
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● Neutral 
● Probably yes 
● Definitely yes 
 
8.4. Questionário Intercorrências 
1) Over the days you used the watch, how many times do you recall the watch asking 
you to perform an electrocardiogram (ECG)? 
 
2) Did you need help to perform the ECG on any of these occasions? 
( ) Yes 
( ) No 
 
3) On any occasion, did you not perform the ECG when the watch prompted you to? 
( ) Yes 
( ) No 
 
4) Did you find it bothersome to perform the ECG? 
( ) Yes 
( ) No 
 
5) If yes, why? 
______________________________________________________________ 
 
 
 
 

                                                                                                                       
 
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