Wearable cardiac monitoring for early arrhythmia detection and remote management

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.