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

Обзор

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.

Вмешательства

• Устройство Smartwatch - all data
  Single-lead ECG, blood pressure (BP), oxygen saturation (SpO2), and continuous heart rate (HR).
• Устройство Portable holter system
  continuous ECG monitoring for 14 days for comparison with the data from the smartwatch
• Процедура Telemonitoring
  Remote consultations triggered by critical alerts based on predefined thresholds.
• Другое AI Model Development
  Data analysis using artificial intelligence for prioritization of patients based on health data collected from wearables.
• Устройство Smartwatch - ECG and HR
  Single-lead ECG and continuous heart rate (HR)

Первичные конечные точки

• Incidence and number of Atrial Fibrillation (AF) events detected [Срок оценки: 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 [Срок оценки: During the monitoring period for each group, as specified (14-45 days depending on group)]
• Patient risk classification generated by the AI model [Срок оценки: During the monitoring period for each group, as specified (14-45 days depending on group)]

Вторичные конечные точки (2)

• Patient risk classification generated by the AI model [Срок оценки: During the monitoring period for each group, as specified (14-45 days depending on group)]
• Adverse events related to device use [Срок оценки: From enrollment through the monitoring period, up to 45 days depending on study group]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Бразилия · 1 центр

• Instituto do Coracao, HCFMUSP — São Paulo

Идентификаторы

NCT: NCT07174206 · 80963624.2.0000.0068

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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