Status:
COMPLETED
FAPO-X: Assisted Digital Telemonitoring With Wearables in Patients After Cardiovascular Surgery
Lead Sponsor:
University of Sao Paulo
Collaborating Sponsors:
Samsung Electronics
Conditions:
Heart; Surgery, Heart, Functional Disturbance as Result
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
This study aims to develop a digitally assisted telemonitoring platform using the Samsung TM Galaxy Watch5 smartwatch, validating the applicability of the solution in patients with POAF (Postoperative...
Detailed Description
This interventional study was conducted exclusively at the Heart Institute of the Clinics Hospital of the Medical School of the University of São Paulo (InCor - HCFMUSP). It was a single-center study ...
Eligibility Criteria
Inclusion
- Age ≥ 22 years;
- Parameters for surgical indication, in the presence of heart disease (mitral or aortic valve disease, coronary artery disease or aortic disease);
- Agree to adhere to the study's procedures and requirements;
- Be able to consent to their participation in writing;
Exclusion
- Not having undergone cardiac surgery;
- Presence of post-surgical complications with prolonged hospital stay for more than 14 days from surgery date;
- Presence of a Peripherally Inserted Central Catheter (PICC) or limb preservation and cardiac pacemaker in case of impediment to acquisition of the ECG (smartwatch);
- Patients with arteriovenous fistula;
- Presence of skin pathology or skin diseases such as vitiligo, lupus and atopic dermatitis, as well as tattoos in the wrist region, which may interfere with the reading by the optical sensor;
- Show sensitivity or allergic reactions, to any degree, to the component materials of the wearable device;
Key Trial Info
Start Date :
February 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2023
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT05966857
Start Date
February 17 2023
End Date
May 23 2023
Last Update
August 1 2023
Active Locations (1)
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1
Instituto do Coracao (Heart Institute), Faculdade de Medicina, Hospital das Clinicas, Universidade de Sao Paulo
São Paulo, São Paulo, Brazil, 05403-900