Heart; Surgery, Heart, Functional Disturbance as ResultFAPO-XNCT05966857
FAPO-X: Assisted Digital Telemonitoring With Wearables in Patients After Cardiovascular Surgery
A study testing Wearable: Smartwatch in people with Heart; Surgery, Heart, Functional Disturbance as Result, run by University of Sao Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Heart; Surgery, Heart, Functional Disturbance as Result
- What is being tested?
- Wearable: Smartwatch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteBrazil
- Study dates
- 17 Feb 2023to 23 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Coracao (Heart Institute), Faculdade de Medicina, Hospital das Clinicas, Universidade de Sao Paulo
São Paulo, São Paulo, 05403-900
About this study
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.
Read the 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 divided into six phases.
The first phase involved outpatient preoperative care, where patients underwent a comprehensive anamnesis during the preoperative consultation and were informed about the study. In the second phase, patients were hospitalized and provided with the Informed Consent Form (ICF) if they met the inclusion criteria. Demographic data were collected during this phase.
During the surgical phase (third phase), intraoperative data were collected after cardiac surgery. The fourth phase focused on postoperative care, where patients were evaluated, and health measures such as blood pressure (BP), heart rate (HR), electrocardiogram (ECG), and peripheral oxygen saturation (SpO2) were collected using the SAMSUNGTM Galaxy Watch5 smartwatch and reference devices.
After discharge, the fifth phase involved a 30-day telemonitoring period, where patients were remotely monitored using the smartwatch. Health data, including BP, HR, ECG, and SpO2, were collected three times a day during this phase. The medical team provided clinical interventions when alerts were received via the "FAPO SI³" platform.
In the final phase, patients returned for an outpatient visit at InCor, where health measures were collected again using the smartwatch and reference devices. Additionally, a World Health Organization Quality of Life (WHOQOL) questionnaire was administered to assess patients' quality of life. ECG reports issued by the smartwatch were also reviewed.
The control group consisted of patients with heart disease who underwent surgical procedures and received standard outpatient and post-surgical follow-up according to institutional routines and protocols.
Overall, the study aimed to develop and validate an assisted digital telemonitoring platform for patients with postoperative atrial fibrillation (POAF). The telemonitored group used the SAMSUNGTM Galaxy Watch5 smartwatch for remote monitoring, while the control group followed standard care protocols.
- Being tested
- Wearable: Smartwatch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable: SmartwatchDevice
The SAMSUNGTM Galaxy Watch5 Smartwatch, is a new generation of smartwatches, features an innovative 3-in-1 BioActive sensor, which uses a chip to capture optical and read cardiac electrical current, allowing to carry out high-quality real-time single-lead electrocardiogram. Despite the more compact design, there is no decrease in accuracy. These signals are then processed by the device's algorithms and can be sent to a trained professional for evaluation immediately after the measurement, facilitating the monitoring and diagnosis of arrhythmias.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (CTL) | No intervention | Patients who underwent standard treatment at the institution without any wearable monitoring. |
| Telemonitored Group (TLM) | Experimental | Patients who received telemonitoring with a Samsung Galaxy smartwatch and FAPO SI³ platform, which is integrated with the hospital's electronic medical record system. Receives: Device: Wearable: Smartwatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rehospitalization rate
Frequency (n, %)
Measured: 30-day
Scheduled consultations
Frequency (n, %)
Measured: 30-day
Extra occurences
Frequency (n, %)
Measured: 30-day
Secondary outcomes (3)
Technological adherence
Frequency (n, %)
Measured: 30-day
Treatment adherence
Frequency (n, %)
Measured: 30-day
Use of the mobile application by patients
Frequency (n, %)
Measured: 30-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start17 Feb 2023
- Primary completion23 May 2023
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Heart; Surgery, Heart, Functional Disturbance as ResultStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This interventional study utilized a parallel assignment model to develop and validate an assisted digital telemonitoring platform for patients with POAF. The telemonitored group received interventions and telemonitoring through the platform, while the control group followed the standard institutional patient journey without any intervention or telemonitoring.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Electronics
- Responsible party
- Principal investigator, Fabio Biscegli Jatene, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966857
- Sponsor's protocol ID
- 66520122.0.0000.0068
- Acronym
- FAPO-X
- Status last verified
- Jul 2023
- First submitted
- 7 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lippi G, Sanchis-Gomar F, Cervellin G. Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. Int J Stroke. 2021 Feb;16(2):217-221. doi: 10.1177/1747493019897870. Epub 2020 Jan 19.
PubMed 31955707Albini A, Malavasi VL, Vitolo M, Imberti JF, Marietta M, Lip GYH, Boriani G. Long-term outcomes of postoperative atrial fibrillation following non cardiac surgery: A systematic review and metanalysis. Eur J Intern Med. 2021 Mar;85:27-33. doi: 10.1016/j.ejim.2020.12.018. Epub 2021 Jan 2.
PubMed 33402281Lopes LA, Agrawal DK. Post-Operative Atrial Fibrillation: Current Treatments and Etiologies for a Persistent Surgical Complication. J Surg Res (Houst). 2022;5(1):159-172. doi: 10.26502/jsr.10020209. Epub 2022 Mar 28.
PubMed 35445200Goulden CJ, Hagana A, Ulucay E, Zaman S, Ahmed A, Harky A. Optimising risk factors for atrial fibrillation post-cardiac surgery. Perfusion. 2022 Oct;37(7):675-683. doi: 10.1177/02676591211019319. Epub 2021 May 26.
PubMed 34034586Phan K, Ha HS, Phan S, Medi C, Thomas SP, Yan TD. New-onset atrial fibrillation following coronary bypass surgery predicts long-term mortality: a systematic review and meta-analysis. Eur J Cardiothorac Surg. 2015 Dec;48(6):817-24. doi: 10.1093/ejcts/ezu551. Epub 2015 Jan 18.
PubMed 25602053Baig MM, GholamHosseini H, Moqeem AA, Mirza F, Linden M. A Systematic Review of Wearable Patient Monitoring Systems - Current Challenges and Opportunities for Clinical Adoption. J Med Syst. 2017 Jul;41(7):115. doi: 10.1007/s10916-017-0760-1. Epub 2017 Jun 19.
PubMed 28631139Tison GH, Sanchez JM, Ballinger B, Singh A, Olgin JE, Pletcher MJ, Vittinghoff E, Lee ES, Fan SM, Gladstone RA, Mikell C, Sohoni N, Hsieh J, Marcus GM. Passive Detection of Atrial Fibrillation Using a Commercially Available Smartwatch. JAMA Cardiol. 2018 May 1;3(5):409-416. doi: 10.1001/jamacardio.2018.0136.
PubMed 29562087Chandrasekaran R, Katthula V, Moustakas E. Patterns of Use and Key Predictors for the Use of Wearable Health Care Devices by US Adults: Insights from a National Survey. J Med Internet Res. 2020 Oct 16;22(10):e22443. doi: 10.2196/22443.
PubMed 33064083Nachman D, Gilan A, Goldstein N, Constantini K, Littman R, Eisenkraft A, Grossman E, Gepner Y. Twenty-Four-Hour Ambulatory Blood Pressure Measurement Using a Novel Noninvasive, Cuffless, Wireless Device. Am J Hypertens. 2021 Nov 20;34(11):1171-1180. doi: 10.1093/ajh/hpab095.
PubMed 34143867
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FAPO-X: Assisted Digital Telemonitoring With Wearables in Patients After Cardiovascular Surgery
- ClinicalTrials.gov ID
- NCT05966857
- Acronym / sponsor ID
- FAPO-X / 66520122.0.0000.0068
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Samsung Electronics
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 divided into six phases.
The first phase involved outpatient preoperative care, where patients underwent a comprehensive anamnesis during the preoperative consultation and were informed about the study. In the second phase, patients were hospitalized and provided with the Informed Consent Form (ICF) if they met the inclusion criteria. Demographic data were collected during this phase.
During the surgical phase (third phase), intraoperative data were collected after cardiac surgery. The fourth phase focused on postoperative care, where patients were evaluated, and health measures such as blood pressure (BP), heart rate (HR), electrocardiogram (ECG), and peripheral oxygen saturation (SpO2) were collected using the SAMSUNGTM Galaxy Watch5 smartwatch and reference devices.
After discharge, the fifth phase involved a 30-day telemonitoring period, where patients were remotely monitored using the smartwatch. Health data, including BP, HR, ECG, and SpO2, were collected three times a day during this phase. The medical team provided clinical interventions when alerts were received via the "FAPO SI³" platform.
In the final phase, patients returned for an outpatient visit at InCor, where health measures were collected again using the smartwatch and reference devices. Additionally, a World Health Organization Quality of Life (WHOQOL) questionnaire was administered to assess patients' quality of life. ECG reports issued by the smartwatch were also reviewed.
The control group consisted of patients with heart disease who underwent surgical procedures and received standard outpatient and post-surgical follow-up according to institutional routines and protocols.
Overall, the study aimed to develop and validate an assisted digital telemonitoring platform for patients with postoperative atrial fibrillation (POAF). The telemonitored group used the SAMSUNGTM Galaxy Watch5 smartwatch for remote monitoring, while the control group followed standard care protocols.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This interventional study utilized a parallel assignment model to develop and validate an assisted digital telemonitoring platform for patients with POAF. The telemonitored group received interventions and telemonitoring through the platform, while the control group followed the standard institutional patient journey without any intervention or telemonitoring.
| Arm | Type | Receives |
|---|---|---|
| Control Group (CTL) | No intervention | –Patients who underwent standard treatment at the institution without any wearable monitoring. |
| Telemonitored Group (TLM) | Experimental | Device: Wearable: SmartwatchPatients who received telemonitoring with a Samsung Galaxy smartwatch and FAPO SI³ platform, which is integrated with the hospital's electronic medical record system. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable: SmartwatchThe SAMSUNGTM Galaxy Watch5 Smartwatch, is a new generation of smartwatches, features an innovative 3-in-1 BioActive sensor, which uses a chip to capture optical and read cardiac electrical current, allowing to carry out high-quality real-time single-lead electrocardiogram. Despite the more compact design, there is no decrease in accuracy. These signals are then processed by the device's algorithms and can be sent to a trained professional for evaluation immediately after the measurement, facilitating the monitoring and diagnosis of arrhythmias. | Device | Telemonitored Group (TLM) |
Primary outcome
Rehospitalization rate
Time frame: 30-day
Frequency (n, %)
Scheduled consultations
Time frame: 30-day
Frequency (n, %)
Extra occurences
Time frame: 30-day
Frequency (n, %)
3 secondary outcomes
Technological adherence
Time frame: 30-day
Treatment adherence
Time frame: 30-day
Use of the mobile application by patients
Time frame: 30-day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Results publication: PubMed 31955707Lippi G, Sanchis-Gomar F, Cervellin G. Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. Int J Stroke. 2021 Feb;16(2):217-221. doi: 10.1177/1747493019897870. Epub 2020 Jan 19.
- Results publication: PubMed 33402281Albini A, Malavasi VL, Vitolo M, Imberti JF, Marietta M, Lip GYH, Boriani G. Long-term outcomes of postoperative atrial fibrillation following non cardiac surgery: A systematic review and metanalysis. Eur J Intern Med. 2021 Mar;85:27-33. doi: 10.1016/j.ejim.2020.12.018. Epub 2021 Jan 2.
- Results publication: PubMed 35445200Lopes LA, Agrawal DK. Post-Operative Atrial Fibrillation: Current Treatments and Etiologies for a Persistent Surgical Complication. J Surg Res (Houst). 2022;5(1):159-172. doi: 10.26502/jsr.10020209. Epub 2022 Mar 28.
- Results publication: PubMed 34034586Goulden CJ, Hagana A, Ulucay E, Zaman S, Ahmed A, Harky A. Optimising risk factors for atrial fibrillation post-cardiac surgery. Perfusion. 2022 Oct;37(7):675-683. doi: 10.1177/02676591211019319. Epub 2021 May 26.
- Results publication: PubMed 25602053Phan K, Ha HS, Phan S, Medi C, Thomas SP, Yan TD. New-onset atrial fibrillation following coronary bypass surgery predicts long-term mortality: a systematic review and meta-analysis. Eur J Cardiothorac Surg. 2015 Dec;48(6):817-24. doi: 10.1093/ejcts/ezu551. Epub 2015 Jan 18.
- Results publication: PubMed 28631139Baig MM, GholamHosseini H, Moqeem AA, Mirza F, Linden M. A Systematic Review of Wearable Patient Monitoring Systems - Current Challenges and Opportunities for Clinical Adoption. J Med Syst. 2017 Jul;41(7):115. doi: 10.1007/s10916-017-0760-1. Epub 2017 Jun 19.
- Results publication: PubMed 29562087Tison GH, Sanchez JM, Ballinger B, Singh A, Olgin JE, Pletcher MJ, Vittinghoff E, Lee ES, Fan SM, Gladstone RA, Mikell C, Sohoni N, Hsieh J, Marcus GM. Passive Detection of Atrial Fibrillation Using a Commercially Available Smartwatch. JAMA Cardiol. 2018 May 1;3(5):409-416. doi: 10.1001/jamacardio.2018.0136.
- Results publication: PubMed 33064083Chandrasekaran R, Katthula V, Moustakas E. Patterns of Use and Key Predictors for the Use of Wearable Health Care Devices by US Adults: Insights from a National Survey. J Med Internet Res. 2020 Oct 16;22(10):e22443. doi: 10.2196/22443.
- Results publication: PubMed 34143867Nachman D, Gilan A, Goldstein N, Constantini K, Littman R, Eisenkraft A, Grossman E, Gepner Y. Twenty-Four-Hour Ambulatory Blood Pressure Measurement Using a Novel Noninvasive, Cuffless, Wireless Device. Am J Hypertens. 2021 Nov 20;34(11):1171-1180. doi: 10.1093/ajh/hpab095.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable: Smartwatch in people with Heart; Surgery, Heart, Functional Disturbance as Result, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rehospitalization rate (time frame: 30-day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05966857, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.