Wearable cardiac monitoring for early arrhythmia detection and remote management
FAPO-2: Cardiac Patient Monitoring Tool for Clinical Observation and Arrhythmia Detection
This project will try a smartwatch-based system to spot arrhythmias early and help manage adults with chronic or recently treated heart problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 520 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | University of Sao Paulo Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT07174206 on ClinicalTrials.gov |
What this trial studies
FAPO-2 is a prospective, interventional, non-randomized study that uses wearable devices and a centralized digital platform to generate automated alerts and trigger teleconsultations for adult cardiac patients. About 520 patients aged 22 and older, stratified by sex, will be enrolled at the Heart Institute (InCor) of the University of São Paulo and followed remotely and in clinic. The intervention combines continuous smartwatch ECG/HR data, a portable Holter system, telemonitoring workflows, and AI model development to enable early arrhythmia detection, remote risk stratification, and timely clinical action. The study will also collect usability and cost-efficiency data to inform real-world implementation.
Who should consider this trial
Good fit: Adults aged 22 or older with diagnosed cardiovascular disease or recent minimally invasive cardiac procedures who can consent and wear a smartwatch are ideal candidates.
Not a fit: Patients with wrist skin conditions or tattoos that interfere with optical sensors, known allergies to device materials, or inability to participate in telemonitoring are unlikely to benefit.
Why it matters
Potential benefit: If successful, it could enable earlier arrhythmia detection and faster clinical response, reducing complications and unnecessary hospital visits.
How similar studies have performed: Previous wearable-based studies have shown promise for detecting atrial fibrillation and supporting remote outpatient care, though evidence on improved long-term clinical outcomes and clear cost savings is still mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
São Paulo, São Paulo
- Instituto do Coracao, HCFMUSP — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: Fabio B Jatene, PhD, MD
- Email: fabio.jatene@incor.usp.br
- Phone: +551126615462
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.