Status:
RECRUITING
FAPO-2: Cardiac Patient Monitoring Tool for Clinical Observation and Arrhythmia Detection
Lead Sponsor:
University of Sao Paulo
Collaborating Sponsors:
Samsung Eletrônica da Amazônia Ltda
Conditions:
Heart Diseases
Atrial Fibrillation (AF)
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
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, cli...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT07174206
Start Date
February 7 2025
End Date
February 28 2026
Last Update
September 15 2025
Active Locations (1)
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1
Instituto do Coracao, HCFMUSP
São Paulo, São Paulo, Brazil, 05403-900