Atrial FibrillationCARE-DETECTNCT05351775
Low Workload Concept for the Detection of Silent Atrial Fibrillation (AF) and Atrial Fibrillation Burden in Patients At High Risk of AF and Stroke
A study testing Smartphone application, Bed sensor and Wrist-worn photoplethysmography (PPG) and accelerometer data logger. in people with Atrial Fibrillation and Arrhythmias, Cardiac, run by University of Turku at 1 site in Finland.
Trial summary
Patient-centered novel e-health technology and services will lay the foundation for future healthcare systems and services to support health and welfare promotion. Yet, there is a lack of ways to incorporate novel technological innovations into easy-to-use, cost-effective and low workload treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases
- What is being tested?
- Smartphone application, Bed sensor and Wrist-worn photoplethysmography (PPG) and accelerometer data logger.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFinland
- Study dates
- 12 Apr 2022to 31 Jan 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- One of listed cardiac operation performed during the index hospitalization:
- open heart surgery (aortic valve replacement (AVR), coronary artery bypass graft (CABG) or combination treatment) or
- percutaneous intervention (transcatheter aortic valve implantation (TAVI) or percutaneous coronary intervention (PCI))
- Patient has been informed on the nature of the study, agrees to its provisions and has provided written informed consent approved by the appropriate Medical Ethics committee.
- In PCI group, the randomization may take place after operation
- Age ≥18 years
Show all 10Show fewer
- CHA2DS2VASC score ≥ 4, or CHA2DS2VASC score ≥ 2 and at least one of the following: ECG P wave duration ≥ 120 ms, left atrial diameter > 38 mm in women or > 40 mm in men, renal impairment (eGFR < 50 ml/min), age ≥ 70 years, active smoking
- Anticipated life expectancy 12 months or more
- Patient is capable of using the study application and bed sensor
- Patient is willing to comply with study specific follow-up evaluations and home-based monitoring
Who cannot join
- Age < 18 years
- Expected survival < 1 year
- Permanent anticoagulation therapy due to atrial fibrillation
- Patient lives outside the catchment area
- Any significant medical condition, which in the Investigator's opinion may interfere with the patient's optimal participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiovascular Research Consortium - a Randomized Prospective Trial to Assess Low Workload Concept for the Detection of Silent Atrial Fibrillation (AF) and Atrial Fibrillation Burden in Patients At High Risk of AF and Stroke
Patient-centered novel e-health technology and services will lay the foundation for future healthcare systems and services to support health and welfare promotion. Yet, there is a lack of ways to incorporate novel technological innovations into easy-to-use, cost-effective and low workload treatment.
The detection of atrial fibrillation (AF) paroxysms and its permanent form as well as the prevention of AF-related strokes are major challenges in cardiology today. AF is often silent or asymptomatic, but the risk of ischemic stroke seems to be similar regardless of the presence or absence of symptoms.
Read more
CARE-DETECT algorithm development part I will investigate following topics:
- The usefulness and validity of bed sensor and mobile phone application in rhythm disorder capture compared to gold standard ECG-holter monitoring (Faros ECG)
- Accuracy of AF detection from PDL data
- Technical development of algorithms to detect arrhythmia from data collected with these novel devices
- Development of a pre-processing tool that will evaluate the collected data and generate a preliminary filtered report of the raw data to ease clinician's workload in data handling and rhythm evaluation.
CARE-DETECT clinical trial (part II) proposal provides a new concept for low workload for healthcare personnel, high diagnostic yield in silent AF detection and AF burden evaluation. CARE-DETECT protocol proposal seeks to address following issues:
- Can a combination of actively used smartphone application and passive monitoring with bed sensor (with upstream ECG) - compared to routine care - enhance the detection of AF in patients who are at increased risk of stroke and have undergone a cardiac procedure?
- What is the actual AF burden in paroxysmal AF patients after the detection of new-onset AF?
- Can a direct-to-consumer telehealth with integrated cloud-based telecardiology service for medical professionals improve the efficacy of silent AF detection and what is the AF burden in patients suffering of (asymptomatic) paroxysmal AF and secondarily what is the cost-effectiveness of these new screening methods?
- Additionally, during the hospitalization phase of the study part II PDL data will be collected in the intervention group. PDL data will be analyzed offline with the purpose to develop new methods and will not be used to monitor treatment or for diagnosis.
Read the detailed description
The detection of atrial fibrillation (AF) paroxysms and its permanent form as well as the prevention of AF-related strokes are major challenges in cardiology today. AF is often silent or asymptomatic, but the risk of ischemic stroke seems to be similar regardless of the presence or absence of symptoms. Asymptomatic AF patients are more likely to evade diagnostic effort and without appropriate anticoagulation they are left vulnerable to thromboembolism and ischemic stroke. Approximately one third of all ischemic strokes are of an unknown cause. Recent studies have shown that more diligent monitoring of heart rhythm with ambulatory devices after a cryptogenic stroke uncovers a high number of silent AF episodes. Timely detection of silent AF is challenging and, therefore, a stroke is still too often the first clinical manifestation of AF accounting for 22% of AF-related strokes. In order to detect symptoms appearing at periodic or random intervals, a capability for longer-term monitoring, e.g. for several days or weeks at a time, is required. Implantable electrocardiogram (ECG) loop recorders perform well in AF detection, but they are hardly feasible in large patient cohorts due to invasive nature and costs. Thus, there is an unmet clinical need for better AF detection tools.
During the Automated Detection of Atrial Fibrillation via a Miniature Accelerometer and Gyroscope (NoStroke) project (as well as other projects carried out simultaneously at Department of Future Technologies, University of Turku, mainly funded by Tekes) a smartphone application has been developed for the detection of AF, which is implemented as a stand-alone solution to a common smartphone. The application utilizes the inbuilt motion sensors of the smartphones without any need to external sensors or equipment, such as electrodes or wires. This application (CardioSignal app) is a CE-marked medical device and will be used in this project and it will provide a venue for a clinical showcase of the application and more importantly, validate whether the application would be beneficial in the clinical settings in this follow-up study.
Bed sensor (Emfit ltd) is a CE-marked device. It is based on ballistography method where a heartbeat-induced recoil can be measured while the subject is lying on the bed. Electromechanical membrane sensor recognizes and registers the recoil, and subsequently, this data can be used to assess heart rate and other relevant vital function. Philips Data Logger (PDL) measures continuously photoplethysmogram (PPG) and accelerometer data from the top side of the wrist using green wavelength Light Emitting Diode (LED) and 3-axis accelerometer. Faros Holter-monitor measures single-lead ECG signal from the chest and is attached via FastFix electrode.
The part I trial is open, prospective interventional trial. These recordings are used merely to technical testing, validity evaluation and algorithm development purposes and the data is not used in any clinical evaluation whatsoever.
The part II is a prospective, randomized, open-label, interventional study. Upon receipt of the signed written informed consent and satisfactory documentation that the patient met all inclusion and had no exclusion criteria, the study subjects will be randomized to either intervention or control arm. The randomization allocation will take into account the procedure subgroup of the patient (open-heart surgery, aortic valve replacement and transcatheter aortic valve implantation (TAVI) or coronary bypass and percutaneous coronary intervention (PCI)). In both subgroups the randomization will be done 1:1. Patients will be randomized before hospital discharge.
The number of study subjects needed was estimated to be 300. Complying with the original plan, interim analysis was performed when 100 cases were enrolled. Based on the interim analysis results, the target enrollment number of patients was reduced to 150 patients due to the high number of false positive alerts leading to high-workload protocol inadequate for clinical use as such.
- Conditions
- Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Pathologic Processes, Postoperative Complications
- Being tested
- Smartphone application, Bed sensor, Wrist-worn photoplethysmography (PPG) and accelerometer data logger., Patch-holter ECG
- Keywords
- Wearable Cardiac Devices, Bed Sensor, Mobile Application, Rhythm Monitoring, Photoplethysmography, Accelerometer, Atrial Fibrillation Screening, Algorithm Development, Silent Atrial Fibrillation, Stroke, Mortality, Economic Evaluation
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Pathologic Processes, Postoperative Complications, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone applicationDevice
Also called CardioSignal app
Patient is asked to do the first recording at hospital to test the device and then preferably twice daily for 1 minute period of time during the 3-month study period.
Bed sensorDevice
Also called Emfit sensor
The Emfit bed sensor will be used during the index hospitalization and in home-based monitoring after hospital discharge up to 3 months.
Wrist-worn photoplethysmography (PPG) and accelerometer data logger.Device
Also called Philips Data Logger
Data collection with PDL is continued during initial hospitalization in the intervention group where the gold standard ECG is obtained and data can be used in algorithm development but will not be used to monitor treatment or for diagnosis.
Patch-holter ECGDevice
Also called Faros Holter
The patch-holter will be used during the index hospitalization and also in home if the home-based monitoring devices are signalling of a possible AF and it is not detected in the consequent ECG.
| Study group | Role | What they receive |
|---|---|---|
| Interventional AF detection arm | Experimental | The patients will be monitored during index hospitalization according normal practice and additionally with a bed sensor, smartphone app, and patch-holter ECG. In addition, patients will have PDL monitoring device during hospitalization. During the index hospitalization, patients will download the CardioSignal app to their own smartphone or if patient does not have a smartphone one can be provided to the patient by the study group. Patients are asked to do the first recordings at hospital to test the device and then preferably twice daily for 1 minute period of time during the 3-month study period. When discharged home, the study subject will have the bed sensor for home-based use up to 3 months. If the average pulse rate in the bed sensor recordings have increased with 20% or the device has recorded rhythm irregularity lasting over 5 minutes (could be longer to reduce false alarms), a 12-lead ECG will be taken, and in the case of a normal ECG, a 7-day Holter monitoring is performed. Receives: Device: Smartphone application; Device: Bed sensor; Device: Wrist-worn photoplethysmography (PPG) and accelerometer data logger.; Device: Patch-holter ECG |
| Standard of care treatment arm | No intervention | Patient will be followed as in routine clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of new AF during index hospitalization.
AF defined by 12-lead ECG or ECG-holter adjudicated by a cardiologist and in borderline cases by two independent cardiologists.
Measured: During hospital stay (assessed up to 10 days).
The rate of new AF burden during index hospitalization.
AF defined by 12-lead ECG or ECG-holter adjudicated by a cardiologist and in borderline cases by two independent cardiologists.
Measured: During hospital stay (assessed up to 10 days).
The rate of new AF during 3 months follow-up after index hospitalization.
AF defined by 12-lead ECG or ECG-holter adjudicated by a cardiologist and in borderline cases by two independent cardiologists.
Measured: During 3 months follow-up.
The rate of new AF burden during 3 months follow-up after index hospitalization.
AF defined by 12-lead ECG or ECG-holter adjudicated by a cardiologist and in borderline cases by two independent cardiologists.
Measured: During 3 months follow-up.
Algorithm development.
The gold standard reference (ECG or Holter) data will be collected to develop an algorithm to detect AF from PPG data.
Measured: The part I trial during index hospitalization (assessed up to 48 hours). The part I trial with PDL may be continued among the part II interventional group during initial hospitalization (assessed up to 10 days) in order to collect additional data.
Number of adverse events related to PDL device.
Although the PDL is safe to use, the user may experience adverse reactions. This is due to wearing the device in contact with the skin for long periods at a time. These reactions include: skin reactions due to pressure of the device on the skin or the device rubbing against the skin, skin reactions due to dirt or moisture in between the device and the skin, skin irritation due to the materials used (colored acrylonitrile butadiene styrene (ABS) and thermoplastic polyurethane (TPU)).
Measured: The part I trial during index hospitalization (assessed up to 48 hours). The part I trial with PDL may be continued among the part II interventional group during initial hospitalization (assessed up to 10 days) in order to collect additional data.
Number of technical issues of the concept and interface.
In part I study the bed sensor technology and mobile phone application will be tested and validated in an open set-up to reliability of the devices and applications before starting the randomized part II of the trial.
Measured: The part I trial during index hospitalization (assessed up to 48 hours).
Number of practical issues of the concept and interface.
In part I study the bed sensor technology and mobile phone application will be tested and validated in an open set-up to usability of the devices and applications before starting the randomized part II of the trial.
Measured: The part I trial during index hospitalization (assessed up to 48 hours).
Secondary outcomes (4)
All-cause mortality.
Postoperative death from any cause. All-cause mortality will be derived from the hospital electronical medical records and The National Causes of Death Register.
Measured: During 12 months follow-up.
Number of Participants with Stroke, TIA and peripheral embolism.
Stroke is defined as a permanent focal neurological deficit adjudicated by a neurologist, and confirmed by computed tomography or magnetic resonance imaging. Transient ischemic attack (TIA) is defined as a transient (<24 hours) focal neurological deficit adjudicated by a neurologist. Peripheral embolism refers to peripheral arterial embolism during follow-up.
Measured: During 12 months follow-up.
Additional costs per detected case of new AF.
The cost-effectiveness (cost/new AF detected) of a direct-to-consumer telehealth with integrated cloud-based telecardiology service for medical professionals in the silent AF detection and in the AF burden screening. Control group has no additional cost because no screening is performed. Intervention group costs consist of device (bedsensor) cost, monthly app fee (smartphone) and cloud server fee. Additionally time and salary of the healthcare professionals (hours) related to work of device alerts.
Measured: During 12 months follow-up.
Number of participants adherent to anticoagulant treatment.
In the patients who receive oral anticoagulant (OAC) prescription, the rate of anticoagulant therapy adherence will be confirmed using a comparison of the medication prescribed at hospital discharge (data in the prescription database) to that derived from the the Drug Reimbursement Register. If patient has not purchased medication, no entry in the Drug Reimbursement Register is seen.
Measured: During 12 months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start12 Apr 2022
- Primary completion23 Apr 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The part I trial is open, prospective interventional trial. These recordings are used merely to technical testing, validity evaluation and algorithm development purposes and the data is not used in any clinical evaluation whatsoever. The part II is a prospective, randomized, open-label, interventional study. Upon receipt of the signed written informed consent and satisfactory documentation that the patient met all inclusion and had no exclusion criteria, the study subjects will be randomized to either intervention or control arm. The randomization allocation will take into account the procedure subgroup of the patient (open-heart surgery, aortic valve replacement and transcatheter aortic valve implantation (TAVI) or coronary bypass and percutaneous coronary intervention (PCI)). In both subgroups the randomization will be done 1:1. Patients will be randomized before hospital discharge.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Electronics Nederland BV, Everon Ltd, Precordior Ltd, Remotea Ltd, Emfit, Corp.
- Responsible party
- Principal investigator, Tuomas Kiviniemi, University of Turku
- Investigators
- Juhani KE Airaksinen, MD, PhD, Study chair, Heart Center, Turku University Hospital and University of Turku, Turku, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351775
- Sponsor's protocol ID
- MOORE4MEDICAL
- Acronym
- CARE-DETECT
- Status last verified
- Mar 2025
- First submitted
- 12 Apr 2022
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fabritz L, Guasch E, Antoniades C, Bardinet I, Benninger G, Betts TR, Brand E, Breithardt G, Bucklar-Suchankova G, Camm AJ, Cartlidge D, Casadei B, Chua WW, Crijns HJ, Deeks J, Hatem S, Hidden-Lucet F, Kaab S, Maniadakis N, Martin S, Mont L, Reinecke H, Sinner MF, Schotten U, Southwood T, Stoll M, Vardas P, Wakili R, West A, Ziegler A, Kirchhof P. Expert consensus document: Defining the major health modifiers causing atrial fibrillation: a roadmap to underpin personalized prevention and treatment. Nat Rev Cardiol. 2016 Apr;13(4):230-7. doi: 10.1038/nrcardio.2015.194. Epub 2015 Dec 24.
PubMed 26701216Sanna T, Diener HC, Passman RS, Di Lazzaro V, Bernstein RA, Morillo CA, Rymer MM, Thijs V, Rogers T, Beckers F, Lindborg K, Brachmann J; CRYSTAL AF Investigators. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. 2014 Jun 26;370(26):2478-86. doi: 10.1056/NEJMoa1313600.
PubMed 24963567Jaakkola J, Mustonen P, Kiviniemi T, Hartikainen JE, Palomaki A, Hartikainen P, Nuotio I, Ylitalo A, Airaksinen KE. Stroke as the First Manifestation of Atrial Fibrillation. PLoS One. 2016 Dec 9;11(12):e0168010. doi: 10.1371/journal.pone.0168010. eCollection 2016.
PubMed 27936187Lehto J, Nuotio J, Relander A, Jaakkola J, Lahdenoja O, Vasankari T, Anzanpour A, Elnaggar I, Rekola R, Sandelin J, Hurnanen T, Airaksinen JK, Koivisto T, Kiviniemi TO. Randomized trial of smartphone application and bed sensor for atrial fibrillation detection in high-risk patients. Sci Rep. 2026 Feb 3;16(1):7088. doi: 10.1038/s41598-026-38273-5.
PubMed 41634330
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Research Consortium - a Randomized Prospective Trial to Assess Low Workload Concept for the Detection of Silent Atrial Fibrillation (AF) and Atrial Fibrillation Burden in Patients At High Risk of AF and Stroke
- ClinicalTrials.gov ID
- NCT05351775
- Acronym / sponsor ID
- CARE-DETECT / MOORE4MEDICAL
- Conditions
- Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Pathologic Processes, Postoperative Complications
- Keywords
- Wearable Cardiac Devices, Bed Sensor, Mobile Application, Rhythm Monitoring, Photoplethysmography, Accelerometer, Atrial Fibrillation Screening, Algorithm Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- Philips Electronics Nederland BV, Everon Ltd, Precordior Ltd, Remotea Ltd, Emfit, Corp.
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 28 Apr 2022 (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.
Patient-centered novel e-health technology and services will lay the foundation for future healthcare systems and services to support health and welfare promotion. Yet, there is a lack of ways to incorporate novel technological innovations into easy-to-use, cost-effective and low workload treatment.
The detection of atrial fibrillation (AF) paroxysms and its permanent form as well as the prevention of AF-related strokes are major challenges in cardiology today. AF is often silent or asymptomatic, but the risk of ischemic stroke seems to be similar regardless of the presence or absence of symptoms.
CARE-DETECT algorithm development part I will investigate following topics:
- The usefulness and validity of bed sensor and mobile phone application in rhythm disorder capture compared to gold standard ECG-holter monitoring (Faros ECG)
- Accuracy of AF detection from PDL data
- Technical development of algorithms to detect arrhythmia from data collected with these novel devices
- Development of a pre-processing tool that will evaluate the collected data and generate a preliminary filtered report of the raw data to ease clinician's workload in data handling and rhythm evaluation.
CARE-DETECT clinical trial (part II) proposal provides a new concept for low workload for healthcare personnel, high diagnostic yield in silent AF detection and AF burden evaluation. CARE-DETECT protocol proposal seeks to address following issues:
- Can a combination of actively used smartphone application and passive monitoring with bed sensor (with upstream ECG) - compared to routine care - enhance the detection of AF in patients who are at increased risk of stroke and have undergone a cardiac procedure?
- What is the actual AF burden in paroxysmal AF patients after the detection of new-onset AF?
- Can a direct-to-consumer telehealth with integrated cloud-based telecardiology service for medical professionals improve the efficacy of silent AF detection and what is the AF burden in patients suffering of (asymptomatic) paroxysmal AF and secondarily what is the cost-effectiveness of these new screening methods?
- Additionally, during the hospitalization phase of the study part II PDL data will be collected in the intervention group. PDL data will be analyzed offline with the purpose to develop new methods and will not be used to monitor treatment or for diagnosis.
Detailed description
The detection of atrial fibrillation (AF) paroxysms and its permanent form as well as the prevention of AF-related strokes are major challenges in cardiology today. AF is often silent or asymptomatic, but the risk of ischemic stroke seems to be similar regardless of the presence or absence of symptoms. Asymptomatic AF patients are more likely to evade diagnostic effort and without appropriate anticoagulation they are left vulnerable to thromboembolism and ischemic stroke. Approximately one third of all ischemic strokes are of an unknown cause. Recent studies have shown that more diligent monitoring of heart rhythm with ambulatory devices after a cryptogenic stroke uncovers a high number of silent AF episodes. Timely detection of silent AF is challenging and, therefore, a stroke is still too often the first clinical manifestation of AF accounting for 22% of AF-related strokes. In order to detect symptoms appearing at periodic or random intervals, a capability for longer-term monitoring, e.g. for several days or weeks at a time, is required. Implantable electrocardiogram (ECG) loop recorders perform well in AF detection, but they are hardly feasible in large patient cohorts due to invasive nature and costs. Thus, there is an unmet clinical need for better AF detection tools.
During the Automated Detection of Atrial Fibrillation via a Miniature Accelerometer and Gyroscope (NoStroke) project (as well as other projects carried out simultaneously at Department of Future Technologies, University of Turku, mainly funded by Tekes) a smartphone application has been developed for the detection of AF, which is implemented as a stand-alone solution to a common smartphone. The application utilizes the inbuilt motion sensors of the smartphones without any need to external sensors or equipment, such as electrodes or wires. This application (CardioSignal app) is a CE-marked medical device and will be used in this project and it will provide a venue for a clinical showcase of the application and more importantly, validate whether the application would be beneficial in the clinical settings in this follow-up study.
Bed sensor (Emfit ltd) is a CE-marked device. It is based on ballistography method where a heartbeat-induced recoil can be measured while the subject is lying on the bed. Electromechanical membrane sensor recognizes and registers the recoil, and subsequently, this data can be used to assess heart rate and other relevant vital function. Philips Data Logger (PDL) measures continuously photoplethysmogram (PPG) and accelerometer data from the top side of the wrist using green wavelength Light Emitting Diode (LED) and 3-axis accelerometer. Faros Holter-monitor measures single-lead ECG signal from the chest and is attached via FastFix electrode.
The part I trial is open, prospective interventional trial. These recordings are used merely to technical testing, validity evaluation and algorithm development purposes and the data is not used in any clinical evaluation whatsoever.
The part II is a prospective, randomized, open-label, interventional study. Upon receipt of the signed written informed consent and satisfactory documentation that the patient met all inclusion and had no exclusion criteria, the study subjects will be randomized to either intervention or control arm. The randomization allocation will take into account the procedure subgroup of the patient (open-heart surgery, aortic valve replacement and transcatheter aortic valve implantation (TAVI) or coronary bypass and percutaneous coronary intervention (PCI)). In both subgroups the randomization will be done 1:1. Patients will be randomized before hospital discharge.
The number of study subjects needed was estimated to be 300. Complying with the original plan, interim analysis was performed when 100 cases were enrolled. Based on the interim analysis results, the target enrollment number of patients was reduced to 150 patients due to the high number of false positive alerts leading to high-workload protocol inadequate for clinical use as such.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The part I trial is open, prospective interventional trial. These recordings are used merely to technical testing, validity evaluation and algorithm development purposes and the data is not used in any clinical evaluation whatsoever. The part II is a prospective, randomized, open-label, interventional study. Upon receipt of the signed written informed consent and satisfactory documentation that the patient met all inclusion and had no exclusion criteria, the study subjects will be randomized to either intervention or control arm. The randomization allocation will take into account the procedure subgroup of the patient (open-heart surgery, aortic valve replacement and transcatheter aortic valve implantation (TAVI) or coronary bypass and percutaneous coronary intervention (PCI)). In both subgroups the randomization will be done 1:1. Patients will be randomized before hospital discharge.
| Arm | Type | Receives |
|---|---|---|
| Interventional AF detection arm | Experimental | Device: Smartphone application, Device: Bed sensor, Device: Wrist-worn photoplethysmography (PPG) and accelerometer data logger., Device: Patch-holter ECGThe patients will be monitored during index hospitalization according normal practice and additionally with a bed sensor, smartphone app, and patch-holter ECG. In addition, patients will have PDL monitoring device during hospitalization. During the index hospitalization, patients will download the CardioSignal app to their own smartphone or if patient does not have a smartphone one can be provided to the patient by the study group. Patients are asked to do the first recordings at hospital to test the device and then preferably twice daily for 1 minute period of time during the 3-month study period. When discharged home, the study subject will have the bed sensor for home-based use up to 3 months. If the average pulse rate in the bed sensor recordings have increased with 20% or the device has recorded rhythm irregularity lasting over 5 minutes (could be longer to reduce false alarms), a 12-lead ECG will be taken, and in the case of a normal ECG, a 7-day Holter monitoring is performed. |
| Standard of care treatment arm | No intervention | –Patient will be followed as in routine clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- One of listed cardiac operation performed during the index hospitalization:
- Patient has been informed on the nature of the study, agrees to its provisions and has provided written informed consent approved by the appropriate Medical Ethics committee.
- In PCI group, the randomization may take place after operation
- Age ≥18 years
- CHA2DS2VASC score ≥ 4, or CHA2DS2VASC score ≥ 2 and at least one of the following: ECG P wave duration ≥ 120 ms, left atrial diameter > 38 mm in women or > 40 mm in men, renal impairment (eGFR < 50 ml/min), age ≥ 70 years, active smoking
Key exclusion criteria (5 listed)
- Age < 18 years
- Expected survival < 1 year
- Permanent anticoagulation therapy due to atrial fibrillation
- Patient lives outside the catchment area
- Any significant medical condition, which in the Investigator's opinion may interfere with the patient's optimal participation in the study.
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 |
|---|---|---|
| Smartphone applicationAlso: CardioSignal appPatient is asked to do the first recording at hospital to test the device and then preferably twice daily for 1 minute period of time during the 3-month study period. | Device | Interventional AF detection arm |
| Bed sensorAlso: Emfit sensorThe Emfit bed sensor will be used during the index hospitalization and in home-based monitoring after hospital discharge up to 3 months. | Device | Interventional AF detection arm |
| Wrist-worn photoplethysmography (PPG) and accelerometer data logger.Also: Philips Data LoggerData collection with PDL is continued during initial hospitalization in the intervention group where the gold standard ECG is obtained and data can be used in algorithm development but will not be used to monitor treatment or for diagnosis. | Device | Interventional AF detection arm |
| Patch-holter ECGAlso: Faros HolterThe patch-holter will be used during the index hospitalization and also in home if the home-based monitoring devices are signalling of a possible AF and it is not detected in the consequent ECG. | Device | Interventional AF detection arm |
Primary outcome
The rate of new AF during index hospitalization.
Time frame: During hospital stay (assessed up to 10 days).
AF defined by 12-lead ECG or ECG-holter adjudicated by a cardiologist and in borderline cases by two independent cardiologists.
The rate of new AF burden during index hospitalization.
Time frame: During hospital stay (assessed up to 10 days).
AF defined by 12-lead ECG or ECG-holter adjudicated by a cardiologist and in borderline cases by two independent cardiologists.
The rate of new AF during 3 months follow-up after index hospitalization.
Time frame: During 3 months follow-up.
AF defined by 12-lead ECG or ECG-holter adjudicated by a cardiologist and in borderline cases by two independent cardiologists.
The rate of new AF burden during 3 months follow-up after index hospitalization.
Time frame: During 3 months follow-up.
AF defined by 12-lead ECG or ECG-holter adjudicated by a cardiologist and in borderline cases by two independent cardiologists.
Algorithm development.
Time frame: The part I trial during index hospitalization (assessed up to 48 hours). The part I trial with PDL may be continued among the part II interventional group during initial hospitalization (assessed up to 10 days) in order to collect additional data.
The gold standard reference (ECG or Holter) data will be collected to develop an algorithm to detect AF from PPG data.
Number of adverse events related to PDL device.
Time frame: The part I trial during index hospitalization (assessed up to 48 hours). The part I trial with PDL may be continued among the part II interventional group during initial hospitalization (assessed up to 10 days) in order to collect additional data.
Although the PDL is safe to use, the user may experience adverse reactions. This is due to wearing the device in contact with the skin for long periods at a time. These reactions include: skin reactions due to pressure of the device on the skin or the device rubbing against the skin, skin reactions due to dirt or moisture in between the device and the skin, skin irritation due to the materials used (colored acrylonitrile butadiene styrene (ABS) and thermoplastic polyurethane (TPU)).
Number of technical issues of the concept and interface.
Time frame: The part I trial during index hospitalization (assessed up to 48 hours).
In part I study the bed sensor technology and mobile phone application will be tested and validated in an open set-up to reliability of the devices and applications before starting the randomized part II of the trial.
Number of practical issues of the concept and interface.
Time frame: The part I trial during index hospitalization (assessed up to 48 hours).
In part I study the bed sensor technology and mobile phone application will be tested and validated in an open set-up to usability of the devices and applications before starting the randomized part II of the trial.
4 secondary outcomes
All-cause mortality.
Time frame: During 12 months follow-up.
Number of Participants with Stroke, TIA and peripheral embolism.
Time frame: During 12 months follow-up.
Additional costs per detected case of new AF.
Time frame: During 12 months follow-up.
Number of participants adherent to anticoagulant treatment.
Time frame: During 12 months follow-up.
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 30 Mar 2025.
- Background: PubMed 26701216Fabritz L, Guasch E, Antoniades C, Bardinet I, Benninger G, Betts TR, Brand E, Breithardt G, Bucklar-Suchankova G, Camm AJ, Cartlidge D, Casadei B, Chua WW, Crijns HJ, Deeks J, Hatem S, Hidden-Lucet F, Kaab S, Maniadakis N, Martin S, Mont L, Reinecke H, Sinner MF, Schotten U, Southwood T, Stoll M, Vardas P, Wakili R, West A, Ziegler A, Kirchhof P. Expert consensus document: Defining the major health modifiers causing atrial fibrillation: a roadmap to underpin personalized prevention and treatment. Nat Rev Cardiol. 2016 Apr;13(4):230-7. doi: 10.1038/nrcardio.2015.194. Epub 2015 Dec 24.
- Background: PubMed 24963567Sanna T, Diener HC, Passman RS, Di Lazzaro V, Bernstein RA, Morillo CA, Rymer MM, Thijs V, Rogers T, Beckers F, Lindborg K, Brachmann J; CRYSTAL AF Investigators. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. 2014 Jun 26;370(26):2478-86. doi: 10.1056/NEJMoa1313600.
- Background: PubMed 27936187Jaakkola J, Mustonen P, Kiviniemi T, Hartikainen JE, Palomaki A, Hartikainen P, Nuotio I, Ylitalo A, Airaksinen KE. Stroke as the First Manifestation of Atrial Fibrillation. PLoS One. 2016 Dec 9;11(12):e0168010. doi: 10.1371/journal.pone.0168010. eCollection 2016.
- Derived from this study: PubMed 41634330Lehto J, Nuotio J, Relander A, Jaakkola J, Lahdenoja O, Vasankari T, Anzanpour A, Elnaggar I, Rekola R, Sandelin J, Hurnanen T, Airaksinen JK, Koivisto T, Kiviniemi TO. Randomized trial of smartphone application and bed sensor for atrial fibrillation detection in high-risk patients. Sci Rep. 2026 Feb 3;16(1):7088. doi: 10.1038/s41598-026-38273-5.
- Individual participant dataSharing planned: No
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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.
Juhani KE Airaksinen, MD, PhD study chair
Heart Center, Turku University Hospital and University of Turku, Turku, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone application, Bed sensor and Wrist-worn photoplethysmography (PPG) and accelerometer data logger. in people with Atrial Fibrillation and Arrhythmias, Cardiac, run by University of Turku at 1 site in Finland.
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 10 inclusion and 5 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 30 Mar 2025. 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 Finland. 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?
The rate of new AF during index hospitalization. (time frame: During hospital stay (assessed up to 10 days).). The study lists 8 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 NCT05351775, which also lists 4 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 30 Mar 2025.