FAPO-X: Assisted Digital Telemonitoring With Wearables in Patients After Cardiovascular Surgery (NCT05966857) | Clinical Trial Compass
CompletedNot Applicable
FAPO-X: Assisted Digital Telemonitoring With Wearables in Patients After Cardiovascular Surgery
Brazil108 participantsStarted 2023-02-17
Plain-language 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 Atrial Fibrillation), along with the accuracy of the smartwatch in detecting vital signs through optical sensors and possibly identifying irregularities in heart rhythm. The validation of its applicability will be carried out through a clinical trial. This is a randomized observational pilot study resulting from the partnership established in the base year of 2022 between InCor and Samsung.
The sample consisted of 108 outpatient patients with cardiac diseases who underwent cardiac surgery and were selected during the preoperative consultation. Subsequently, the patients were randomized (1:1) into the intervention group (teleassisted group) or the control group (standard institution follow-up).
The sample size was proposed by the contracting party as this is a pilot study to assess whether the implementation of a technological solution assists in monitoring and predicting the risk of surgical patients in the postoperative phase, as well as the accuracy of the Samsung TM Galaxy Watch5 smartwatch in a sample with POAF.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.