Condition: Heart Diseases · Atrial Fibrillation (AF) · Angina, Unstable · Sponsor: University of Sao Paulo
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-le…
This description comes directly from the study's public registry record.
Fabio B Jatene, PhD, MD · +551126615462 · fabio.jatene@incor.usp.br
Rosangela Monteiro, PhD · +551126615197 · rosangela.monteiro@incor.usp.br
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| Instituto do Coracao, HCFMUSP | São Paulo, São Paulo, Brazil | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07174206