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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

520 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-07

Study Completion Date

2026-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Diseases Atrial Fibrillation (AF) Angina, Unstable

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

ECG Reader: The ECG reader will analyze the ECGs without access to identifiable participant information, ensuring that the interpretation of data is done blindly, without bias related to the patient's identity.

AI Model Developer: The developer will also work with anonymized data, meaning they will not have access to personal information of the participants, ensuring the integrity and confidentiality of the data during model development.

Intervention Type DEVICE

Single-lead ECG and continuous heart rate (HR)

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No