[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606334":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":37,"centralContacts":55,"locations":65,"responsibleParty":83,"collaborators":87,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":37,"enrollmentInfo":100,"targetDuration":37,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":111,"overallStatus":68,"whyStopped":37,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"University of Sao Paulo","OTHER",[8,17,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13,14,15,16],"Device: Smartwatch - all data","Device: Portable holter system","Procedure: Telemonitoring","Other: AI Model Development",{"label":18,"type":19,"description":20,"interventionNames":21},"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.",[13,14,15,16],{"label":23,"type":19,"description":24,"interventionNames":25},"Extensive Post-Intervention Monitoring","Patients who have recently undergone minimally invasive cardiovascular procedures such as angioplasty, transcatheter aortic valve implantation (TAVI), or catheter ablation. Monitoring occurs over 45±3 days. For 30 days, participants use the smartwatch to collect blood pressure, oxygen saturation (SpO2), heart rate (HR), and single-lead ECG. Also, for 15 days, both the smartwatch (HR and ECG only) and the portable holter system are used simultaneously, with the portable holter system providing continuous ECG monitoring.",[13,14,15,16],{"label":27,"type":19,"description":28,"interventionNames":29},"Optimized Outpatient Monitoring","Patients with stable chronic cardiac disease monitored for 15±3 days using both the smartwatch captures heart rate and single-lead ECG, while the portable holter system provides continuous ECG monitoring.",[14,15,16,30],"Device: Smartwatch - ECG and HR",[32,38,42,47,51],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DEVICE","Smartwatch - all data","Single-lead ECG, blood pressure (BP), oxygen saturation (SpO2), and continuous heart rate (HR).",[18,23,9],null,{"type":33,"name":39,"description":40,"armGroupLabels":41,"otherNames":37},"Portable holter system","continuous ECG monitoring for 14 days for comparison with the data from the smartwatch",[18,23,27,9],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":37},"PROCEDURE","Telemonitoring","Remote consultations triggered by critical alerts based on predefined thresholds.",[18,23,27,9],{"type":6,"name":48,"description":49,"armGroupLabels":50,"otherNames":37},"AI Model Development","Data analysis using artificial intelligence for prioritization of patients based on health data collected from wearables.",[18,23,27,9],{"type":33,"name":52,"description":53,"armGroupLabels":54,"otherNames":37},"Smartwatch - ECG and HR","Single-lead ECG and continuous heart rate (HR)",[27],[56,61],{"name":57,"role":58,"phone":59,"phoneExt":37,"email":60},"Fabio B Jatene, PhD, MD","CONTACT","+551126615462","fabio.jatene@incor.usp.br",{"name":62,"role":58,"phone":63,"phoneExt":37,"email":64},"Rosangela Monteiro, PhD","+551126615197","rosangela.monteiro@incor.usp.br",[66],{"facility":67,"status":68,"city":69,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Instituto do Coracao, HCFMUSP","RECRUITING","São Paulo","05403-900","Brazil","BR",{"type":74,"coordinates":75},"Point",[76,77],-46.63611,-23.5475,{"lat":77,"lon":76},[80],{"name":81,"role":58,"phone":82,"phoneExt":37,"email":60},"Fabio Biscegli Jatene, MD, PhD","+551126615318",{"type":84,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"PRINCIPAL_INVESTIGATOR","Fabio Biscegli Jatene","Full Professor of Cardiovascular Surgery at the University of São Paulo Medical School (FMUSP) and General Director of InCor-HCFMUSP",[88],{"name":89,"class":90},"Samsung Eletrônica da Amazônia Ltda","UNKNOWN","100606334","fapo-2-cardiac-patient-monitoring-tool-for-clinical-observation-and-arrhythmia-detection-100606334",false,"NCT07174206","FAPO-2: Cardiac Patient Monitoring Tool for Clinical Observation and Arrhythmia Detection","FAPO-2","Inclusion Criteria:\n\n* Patients diagnosed with cardiovascular disease, of both sexes, aged over 22 years;\n* Provision of informed consent through signature of the Informed Consent Form (ICF);\n* Assentation to adhere to study procedures and requirements;\n* 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.);\n* Low or no risk of skin injury, based on Braden Scale clinical criteria or clinical team assessment\n\nExclusion Criteria:\n\n* 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;\n* Known sensitivity or history of allergic reactions to components of the wearable devices or related items, such as adhesives or electrodes;\n* Inability to properly use the wearable monitoring devices due to physical, cognitive, or technological limitations;\n* Presence of a peripherally inserted central catheter (PICC) or arteriovenous fistula;\n* Presence of implanted cardiac devices, such as pacemakers, defibrillators, or cardiac resynchronization devices, which prevent ECG acquisition via smartwatch;\n* 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.","ALL","22 Years",{"count":101,"type":102},520,"ESTIMATED","INTERVENTIONAL",[105],"NA","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:\n\nGroup 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.\n\nGroup 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.\n\nGroup 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.\n\nGroup 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.",[108,109,110],"Heart Diseases","Atrial Fibrillation (AF)","Angina, Unstable",[112,113,114,44,115,116],"Atrial Fibrillation","FAPO","PAOF","Digital Health","Arrhythmias","2025-09-08",{"date":119,"type":120},"2025-09-15","ACTUAL",{"date":122,"type":120},"2025-02-07",{"date":124,"type":102},"2026-02-28",{"name":5,"class":6},1]