Heart DiseasesFAPO-2NCT07174206
FAPO-2: Cardiac Patient Monitoring Tool for Clinical Observation and Arrhythmia Detection
A study testing Smartwatch - all data, Portable holter system and Telemonitoring in people with Heart Diseases and Atrial Fibrillation (AF), run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Heart Diseases, Atrial Fibrillation (AF), Angina, Unstable
- What is being tested?
- Smartwatch - all data, Portable holter system and Telemonitoring
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Feb 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Coracao, HCFMUSP
São Paulo, São Paulo, 05403-900
Fabio Biscegli Jatene, MD, PhD, +551126615318, fabio.jatene@incor.usp.br
About this study
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.
Read more
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.
- Conditions
- Heart Diseases, Atrial Fibrillation (AF), Angina, Unstable
- Being tested
- Smartwatch - all data, Portable holter system, Telemonitoring, AI Model Development, Smartwatch - ECG and HR
- Keywords
- Atrial Fibrillation, FAPO, PAOF, Telemonitoring, Digital Health, Arrhythmias
- Medical subject headings
- Heart Diseases, Atrial Fibrillation, Angina, Unstable, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartwatch - all dataDevice
Single-lead ECG, blood pressure (BP), oxygen saturation (SpO2), and continuous heart rate (HR).
Portable holter systemDevice
continuous ECG monitoring for 14 days for comparison with the data from the smartwatch
TelemonitoringProcedure or surgery
Remote consultations triggered by critical alerts based on predefined thresholds.
AI Model DevelopmentOther
Data analysis using artificial intelligence for prioritization of patients based on health data collected from wearables.
Smartwatch - ECG and HRDevice
Single-lead ECG and continuous heart rate (HR)
| Study group | Role | What they receive |
|---|---|---|
| Pilot Group | Experimental | 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. Receives: Device: Smartwatch - all data; Device: Portable holter system; Procedure: Telemonitoring; Other: AI Model Development |
| Extensive Ambulatory Monitoring Group | Active comparator | 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. Receives: Device: Smartwatch - all data; Device: Portable holter system; Procedure: Telemonitoring; Other: AI Model Development |
| Extensive Post-Intervention Monitoring | Active comparator | 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. Receives: Device: Smartwatch - all data; Device: Portable holter system; Procedure: Telemonitoring; Other: AI Model Development |
| Optimized Outpatient Monitoring | Active comparator | 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. Receives: Device: Portable holter system; Procedure: Telemonitoring; Other: AI Model Development; Device: Smartwatch - ECG and HR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and number of Atrial Fibrillation (AF) events detected
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.
Measured: During the monitoring period for each group, as specified (14-45 days depending on group)
Number of critical health alerts generated by the FAPO-SI³ platform
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.
Measured: During the monitoring period for each group, as specified (14-45 days depending on group)
Patient risk classification generated by the AI model
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.
Measured: During the monitoring period for each group, as specified (14-45 days depending on group)
Secondary outcomes (2)
Patient risk classification generated by the AI model
Distribution of patients across AI-generated risk categories adapted from the Manchester Triage System. The algorithm will classify patients into risk levels (e.g., immediate, very urgent, urgent, standard, non-urgent) based on physiological and biometric data collected from the smartwatch and portable Holter system during the monitoring period.
Measured: During the monitoring period for each group, as specified (14-45 days depending on group)
Adverse events related to device use
Incidence of device-related adverse events including skin lesions (MARSI), allergic reactions, and discomfort (graded using validated scales) reported during the monitoring period.
Measured: From enrollment through the monitoring period, up to 45 days depending on study group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start7 Feb 2025
- Primary completion31 Jan 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- FAPO-2 adopts a prospective, single-group interventional study model in which all participants are remotely monitored using both the smartwatch and a portable holter system. The intervention consists of a structured teleconsultation model triggered by predefined clinical thresholds and critical patterns identified through continuous data integration on the FAPO-SI³ platform. Physiological and biometric data are collected viaHealth applications and transmitted daily (D+1) to the clinical team for near-real-time review. Upon detection of critical events or out-of-range parameters, the system automatically generates alerts that prompt nurse- or physician-led teleconsultations. During these teleconsultations, patient symptoms are evaluated, medication regimens may be adjusted, and decisions are made regarding the need for in-person clinical evaluation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Eletrônica da Amazônia LTDA
- Responsible party
- Principal investigator, Fabio Biscegli Jatene, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174206
- Sponsor's protocol ID
- 80963624.2.0000.0068
- Acronym
- FAPO-2
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant monitoring will be conducted by the multidisciplinary team via the SI³ platform, allowing near real-time detection of clinical events and prompt intervention. After study completion, all data will be anonymized and analyzed by the InCor team. De-identified datasets may be shared with the sponsor and affiliated entities. No personally identifiable information will be disclosed. All data sharing will comply with ethical and legal data protection standards.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FAPO-2: Cardiac Patient Monitoring Tool for Clinical Observation and Arrhythmia Detection
- ClinicalTrials.gov ID
- NCT07174206
- Acronym / sponsor ID
- FAPO-2 / 80963624.2.0000.0068
- Conditions
- Heart Diseases, Atrial Fibrillation (AF), Angina, Unstable
- Keywords
- Atrial Fibrillation, FAPO, PAOF, Telemonitoring, Digital Health, Arrhythmias
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Samsung Eletrônica da Amazônia LTDA
- Study start
- 7 Feb 2025 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- FAPO-2 adopts a prospective, single-group interventional study model in which all participants are remotely monitored using both the smartwatch and a portable holter system. The intervention consists of a structured teleconsultation model triggered by predefined clinical thresholds and critical patterns identified through continuous data integration on the FAPO-SI³ platform. Physiological and biometric data are collected viaHealth applications and transmitted daily (D+1) to the clinical team for near-real-time review. Upon detection of critical events or out-of-range parameters, the system automatically generates alerts that prompt nurse- or physician-led teleconsultations. During these teleconsultations, patient symptoms are evaluated, medication regimens may be adjusted, and decisions are made regarding the need for in-person clinical evaluation.
| Arm | Type | Receives |
|---|---|---|
| Pilot Group | Experimental | Device: Smartwatch - all data, Device: Portable holter system, Procedure: Telemonitoring, Other: AI Model DevelopmentHealthy 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. |
| Extensive Ambulatory Monitoring Group | Active comparator | Device: Smartwatch - all data, Device: Portable holter system, Procedure: Telemonitoring, Other: AI Model DevelopmentPatients 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. |
| Extensive Post-Intervention Monitoring | Active comparator | Device: Smartwatch - all data, Device: Portable holter system, Procedure: Telemonitoring, Other: AI Model DevelopmentPatients 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. |
| Optimized Outpatient Monitoring | Active comparator | Device: Portable holter system, Procedure: Telemonitoring, Other: AI Model Development, Device: Smartwatch - ECG and HRPatients 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartwatch - all dataSingle-lead ECG, blood pressure (BP), oxygen saturation (SpO2), and continuous heart rate (HR). | Device | Extensive Ambulatory Monitoring Group, Extensive Post-Intervention Monitoring, Pilot Group |
| Portable holter systemcontinuous ECG monitoring for 14 days for comparison with the data from the smartwatch | Device | Extensive Ambulatory Monitoring Group, Extensive Post-Intervention Monitoring, Optimized Outpatient Monitoring, Pilot Group |
| TelemonitoringRemote consultations triggered by critical alerts based on predefined thresholds. | Procedure or surgery | Extensive Ambulatory Monitoring Group, Extensive Post-Intervention Monitoring, Optimized Outpatient Monitoring, Pilot Group |
| AI Model DevelopmentData analysis using artificial intelligence for prioritization of patients based on health data collected from wearables. | Other | Extensive Ambulatory Monitoring Group, Extensive Post-Intervention Monitoring, Optimized Outpatient Monitoring, Pilot Group |
| Smartwatch - ECG and HRSingle-lead ECG and continuous heart rate (HR) | Device | Optimized Outpatient Monitoring |
Primary outcome
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.
2 secondary outcomes
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)
Adverse events related to device use
Time frame: From enrollment through the monitoring period, up to 45 days depending on study group
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: Yes. Participant monitoring will be conducted by the multidisciplinary team via the SI³ platform, allowing near real-time detection of clinical events and prompt intervention. After study completion, all data will be anonymized and analyzed by the InCor team. De-identified datasets may be shared with the sponsor and affiliated entities. No personally identifiable information will be disclosed. All data sharing will comply with ethical and legal data protection standards.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartwatch - all data, Portable holter system and Telemonitoring in people with Heart Diseases and Atrial Fibrillation (AF), run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabio B Jatene, PhD, MD (+551126615462, fabio.jatene@incor.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.