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

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.