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

Status: Recruiting
Location: See location...
Intervention Type: Other, Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The FAPO-2 study (Patient Monitoring Tool for Clinical Observation and Arrhythmia Detection) is a prospective, interventional, non-randomized study designed to evaluate the feasibility, usability, clinical effectiveness, and cost-efficiency of a wearable-enabled remote monitoring strategy in adult cardiac patients. The intervention consists of active clinical management of patients via teleconsultations, triggered by automated alerts generated through wearable data integrated into a centralized digital platform. FAPO-2 will include patients with chronic cardiovascular conditions and those undergoing recent minimally invasive interventions. The central objective is to validate a structured model for early arrhythmia detection, remote risk stratification, and timely clinical action. A total of 520 patients aged ≥22 years will be enrolled, stratified by sex (1:1), and followed at the Heart Institute (InCor) of the University of São Paulo. Participants will be allocated into one of four protocol groups: Group 1 - Pilot (n=15): Healthy volunteers monitored for \ 14±3 days using both the smartwatch and a portable holter system to validate usability, skin tolerability, signal integrity, and data flow within the platform. Group 2 - Extensive Outpatient Monitoring (n=150): Patients with chronic cardiovascular diseases monitored over a 45-day period. During 30 days, monitoring will be performed using a smartwatch to capture blood pressure, oxygen saturation, heart rate, and single-lead ECG. For 15 days, participants will use both the smartwatch (for HR and ECG) and a portable holter system. Group 3 - Extensive Post-Intervention Monitoring (n=50): Patients recently undergoing procedures such as angioplasty, TAVI, or ablation, following the same monitoring protocol as Group 2. Group 4 - Optimized Outpatient Monitoring (n=305): Patients with stable chronic cardiac disease monitored for 15±3 days, using both devices simultaneously for HR and ECG (smartwatch) and portable holter system.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Brazil
Instituto do Coracao, HCFMUSP
RECRUITING
São Paulo
Contact Information
Primary
Fabio B Jatene, PhD, MD
fabio.jatene@incor.usp.br
+551126615462
Backup
Rosangela Monteiro, PhD
rosangela.monteiro@incor.usp.br
+551126615197
Time Frame
Start Date: 2025-02-07
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 520
Treatments
Experimental: Pilot Group
Healthy volunteers monitored for \~14±3 days using both a smartwatch and a portable holter system to validate usability, skin tolerability, signal integrity, and data flow within the platform.
Active_comparator: Extensive Ambulatory Monitoring Group
Patients with chronic cardiovascular diseases monitored over 45±3 days. For 30 days, participants use the smartwatch to collect blood pressure, oxygen saturation (SpO2), heart rate (HR), and sigle-lead ECG. Also, for 15 days, participants use both smartwatch (HR and ECG only) and portable holter system simultaneously, with the patch providing continuous ECG monitoring.
Active_comparator: 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.
Active_comparator: 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.
Sponsors
Leads: University of Sao Paulo
Collaborators: Samsung Eletrônica da Amazônia Ltda

This content was sourced from clinicaltrials.gov