Atrial Fibrillation New OnsetNOTE-AFNCT06600620
Intelligent Monitoring to Predict Atrial Fibrillation
An observational study of Atrial Fibrillation New Onset and Postoperative Cardiovascular Complications, run by Liverpool University Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
Atrial Fibrillation (AF) is the commonest arrhythmia worldwide, affects 5% of people over the age of 65 and increases the risk of stroke and heart failure. The investigators aim to detect clinical and subclinical episodes of atrial fibrillation lasting \>30 seconds to develop risk prediction models to… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Atrial Fibrillation New Onset, Postoperative Cardiovascular Complications, Atrial Fibrillation
- What is being tested?
- Monitoring patients heart rythms with a wireless patch device
- Type of treatment
- Medical device
- How many people
- 1,200 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 23 Sep 2024to 1 Aug 2028
- Phase
- Observational
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to hospital with a variety of medical conditions
Who may be able to join
- Adult patients ≥50 years
- Estimated risk of developing new episodes of AF greater than 5%
- Sinus rhythm at presentation
- One of the following acute conditions:
- Patients admitted or referred to Critical Care (NOTE-AF ICU)
- Patients admitted to hospital with acute heart failure (NOTE-AF HF)
Show all 11Show fewer
- Patients admitted to Emergency Services with sepsis or infection (NOTE-AF Sepsis)
- Patients post upper gastrointestinal surgery (NOTE-AF PULSE-GI)
- Patients post vascular interventions (NOTE-AF Vasc)
- Patients with acute respiratory failure (NOTE-AF Resp)
- Patients admitted after acute stroke (NOTE-AF stroke)
Who cannot join
- Atrial fibrillation or atrial flutter at the time of screening
- Patients in atrial fibrillation or atrial flutter at time of preoperative assessment or admission to hospital
- Paced cardiac rhythm
- Inability to obtain consent
- Allergy to plaster or silicone
- Expected hospital stay less than 48 hours
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Liverpool university foundation trust
Liverpool
Liverpool University hospital Foundation trust
Liverpool
About this study
Official title: Intelligent Monitoring to Predict Atrial Fibrillation [NOTE-AF]: Clinical Study 1 for the "Health Virtual Twins for the Personalised Management of Stroke Related to Atrial Fibrillation (TARGET)" Project
Atrial Fibrillation (AF) is the commonest arrhythmia worldwide, affects 5% of people over the age of 65 and increases the risk of stroke and heart failure. The investigators aim to detect clinical and subclinical episodes of atrial fibrillation lasting \>30 seconds to develop risk prediction models to identify patients at high risk for ischaemic stroke.
Read the detailed description
Atrial Fibrillation (AF) is the commonest arrhythmia worldwide, affects 5% of people over the age of 65 and increases the risk of stroke and heart failure. Among acutely unwell patients; arrhythmias and myocardial injury are common and associated with increased mortality, morbidity, and healthcare costs. Cardiovascular comorbidities in these high-risk patients include hypertension (47%), dyslipidaemia (29%) and ischaemic heart disease (11%).
The investigators aim to detect clinical and subclinical episodes of atrial fibrillation lasting 30 seconds to develop risk prediction models to identify patients at high risk for ischaemic stroke. Data will serve to develop and validate bedside clinical decision support tools and digital twins. Patients who develop episodes of AF as part of acute illness, will suffer further episodes of AF within one year in over 20% of cases with 27% progressing to paroxysmal/permanent AF. The true incidence of AF is unknown in acutely unwell patients as a significant percentage of AF episodes remain undetected with conventional intermittent monitoring. Patients experiencing short self-terminating episodes of AF carry a 5-fold risk of developing continuous AF and double the risk of stroke and thromboembolic events. Patients suffering episodes of AF often remain asymptomatic but are at increased risk of heart failure and death at one year. Compared to routine intermittent manual measurement of vital signs, wireless continuous vital sign monitoring systems (wCVSM) detect deviations instantaneously with the option of alerting clinical staff in real time via mobile phone applications. Accurate categorization of alerts into false and true events is essential for developing intelligent software that can be embedded into monitoring systems. Continuous ECG and vital signs monitoring can detect AF episodes more reliable, trigger timely investigations and support longer term treatment plans.
Changes in patient pathways and introduction of novel devices to alert healthcare staff on the potential of clinical events require buy-in from all stakeholders. It is therefore essential to evaluate user acceptance and to determine perceptions of users before rolling out a novel patient pathways or implementation of a new device within an organization. The investigators therefore wish to explore users\' views of the device, wearing the device and potential areas for improvement using questionnaires for patients and health care staff and by conducting semi-structured interviews with healthcare staff.
Primary objective To determine the true cardiovascular event rate (defined as at least one of the following criteria: episodes of AF, New Regional Wall Motion Abnormalities, raised cardiac biomarkers hs-troponin T and NT-pro-BNP) versus false cardiovascular events detected by continuous wireless remote monitoring.
Secondary objective To determine patient acceptability and usability for health care professionals of a novel remote monitoring device with automated alert function.
- Conditions
- Atrial Fibrillation New Onset, Postoperative Cardiovascular Complications, Atrial Fibrillation
- Being tested
- Monitoring patients heart rythms with a wireless patch device
- Keywords
- atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring patients heart rythms with a wireless patch deviceDevice
The investigators will collect data in patients at high risk of atrial fibrillation (AF) without a known history of AF to determine clinical predicators of AF. This data will be used to generate virtual digital twins to to predict clinical and subclinical episodes of AF
| Study group | Role | What they receive |
|---|---|---|
| Patients admitted or referred to Critical Care (NOTE-AF ICU) | Patients admitted or referred to Critical Care Receives: Device: Monitoring patients heart rythms with a wireless patch device | |
| Patients admitted to hospital with acute heart failure (NOTE-AF HF) | Patients admitted to hospital with acute heart failure Receives: Device: Monitoring patients heart rythms with a wireless patch device | |
| Patients admitted to Emergency Services with sepsis or infection (NOTE-AF Sepsis) | Patients admitted to Emergency Services with sepsis or infection Receives: Device: Monitoring patients heart rythms with a wireless patch device | |
| Patients post upper gastrointestinal surgery (NOTE-AF PULSE-GI) | Patients post upper gastrointestinal surgery Receives: Device: Monitoring patients heart rythms with a wireless patch device | |
| Patients post vascular interventions (NOTE-AF Vasc) | Patients post vascular interventions Receives: Device: Monitoring patients heart rythms with a wireless patch device | |
| Patients with acute respiratory failure (NOTE-AF Resp) | Patients with acute respiratory failure Receives: Device: Monitoring patients heart rythms with a wireless patch device | |
| Patients admitted after acute stroke (NOTE-AF stroke) | Patients admitted after acute stroke Receives: Device: Monitoring patients heart rythms with a wireless patch device |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the incidence of clinical and subclinical episodes of AF in acutely unwell patients and to generate data for the development and validation of virtual twins and clinical decision support tools.
- Number of participants with device detected AF lasting greater than 30 seconds
Measured: 48 months
To determine the incidence of clinical and subclinical episodes of AF in acutely unwell patients and to generate data for the development and validation of virtual twins and clinical decision support tools.
Number of episodes of AF and duration of each AF episode
Measured: 48 months
Secondary outcomes (18)
Length of hospital stay
As measured in days and hours
Measured: 48 months
Hospital readmissions within 90 days
Number of readmissions and admission diagnosis of hospital readmissions
Measured: 48 months
Recurrence of AF episodes
Recurrence of AF post discharge as gathered from primary care and secondary care records.
Measured: 48 months
Hospital and 90-day Mortality
Inhospital and 90-day mortality
Measured: 48 months
Time spent in AF
Length of time in AF whilst on monitoring device
Measured: 48 months
Number of AF episodes
Number of AF episodes whilst on monitoring device
Measured: 48 months
Complications of AF
Inhospital and 90 day complications of AF such as stroke, thromboembolic disease \& heart failure
Measured: 48 months
High sensitivity Troponin concentrations in patients with AF episodes
Troponin changes (measured by Hs-Trop T) in patients with episodes of AF
Measured: 48 months
Echocardiographic changes in patients with AF episodes
As measured by advanced echocardiographic parameters including but not limited to left atrial conduit strain, left atrial booster strain, left atrial stiffness and left atrial strain
Measured: 48 months
mHealth App Usability Questionnaire
MAUQ score of patients with wireless observations
Measured: 48 months
Percentage change of troponin concentrations in patients with and without episodes of AF
Change in troponin levels in patients with and without episodes of AF
Measured: 48 months
Time wireless continuous vital signs monitoring device is attached
Measured in hours and minutes
Measured: 48 months
Number of cardiovascular alerts
Number of cardiovascular alerts registered by device
Measured: 48 months
Number of non-cardiovascular alerts
Number of non-cardiovascular alerts registered by device
Measured: 48 months
Number of alerts reflecting clinical changes
Number of alerts via continuous vital signs monitoring device
Measured: 48 months
Number of alerts reflecting artefacts or non-clinical events
Number of alerts reflecting clinical deterriorations versus number of alerts reflecting clinical deterrioation
Measured: 48 months
RWMA score, atrial size and volume, left ventricular strain rate, standard echocardiographic measurements as per british society of echocardiography recommendations
Echocardiographic predictors of AF
Measured: 48 months
Change in inflammatory markers white cell count, C-reactive protein and procalcitonin over time
Change in blood tests in patients with and without new-onset AF
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start23 Sep 2024
- Primary completion31 Jul 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Why it stopped: logistical issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation New OnsetStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- University of Copenhagen, Isansys Lifecare LTD, University of Liverpool, Liverpool John Moores University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600620
- Sponsor's protocol ID
- JRO-0126
- Acronym
- NOTE-AF
- Status last verified
- Jun 2025
- First submitted
- 12 Sep 2024
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided at this point in time
Publications
Essa H, Johnston B, Lip GYH, Ortega-Martorell S, Williams K, Welters ID; TARGET Consortium. Intelligent monitoring to predict atrial fibrillation (NOTE-AF): clinical study 1 for the 'Health virtual twins for the personalised management of stroke related to atrial fibrillation (TARGET)' project - a protocol for a prospective cohort analysis. BMJ Open. 2026 Jan 3;16(1):e099658. doi: 10.1136/bmjopen-2025-099658.
PubMed 41485778
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intelligent Monitoring to Predict Atrial Fibrillation [NOTE-AF]: Clinical Study 1 for the "Health Virtual Twins for the Personalised Management of Stroke Related to Atrial Fibrillation (TARGET)" Project
- ClinicalTrials.gov ID
- NCT06600620
- Acronym / sponsor ID
- NOTE-AF / JRO-0126
- Conditions
- Atrial Fibrillation New Onset, Postoperative Cardiovascular Complications, Atrial Fibrillation
- Keywords
- atrial fibrillation
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: logistical issues
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Collaborators
- University of Copenhagen, Isansys Lifecare LTD, University of Liverpool, Liverpool John Moores University
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 19 Sep 2024 (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.
Atrial Fibrillation (AF) is the commonest arrhythmia worldwide, affects 5% of people over the age of 65 and increases the risk of stroke and heart failure. The investigators aim to detect clinical and subclinical episodes of atrial fibrillation lasting \>30 seconds to develop risk prediction models to identify patients at high risk for ischaemic stroke.
Detailed description
Atrial Fibrillation (AF) is the commonest arrhythmia worldwide, affects 5% of people over the age of 65 and increases the risk of stroke and heart failure. Among acutely unwell patients; arrhythmias and myocardial injury are common and associated with increased mortality, morbidity, and healthcare costs. Cardiovascular comorbidities in these high-risk patients include hypertension (47%), dyslipidaemia (29%) and ischaemic heart disease (11%).
The investigators aim to detect clinical and subclinical episodes of atrial fibrillation lasting 30 seconds to develop risk prediction models to identify patients at high risk for ischaemic stroke. Data will serve to develop and validate bedside clinical decision support tools and digital twins. Patients who develop episodes of AF as part of acute illness, will suffer further episodes of AF within one year in over 20% of cases with 27% progressing to paroxysmal/permanent AF. The true incidence of AF is unknown in acutely unwell patients as a significant percentage of AF episodes remain undetected with conventional intermittent monitoring. Patients experiencing short self-terminating episodes of AF carry a 5-fold risk of developing continuous AF and double the risk of stroke and thromboembolic events. Patients suffering episodes of AF often remain asymptomatic but are at increased risk of heart failure and death at one year. Compared to routine intermittent manual measurement of vital signs, wireless continuous vital sign monitoring systems (wCVSM) detect deviations instantaneously with the option of alerting clinical staff in real time via mobile phone applications. Accurate categorization of alerts into false and true events is essential for developing intelligent software that can be embedded into monitoring systems. Continuous ECG and vital signs monitoring can detect AF episodes more reliable, trigger timely investigations and support longer term treatment plans.
Changes in patient pathways and introduction of novel devices to alert healthcare staff on the potential of clinical events require buy-in from all stakeholders. It is therefore essential to evaluate user acceptance and to determine perceptions of users before rolling out a novel patient pathways or implementation of a new device within an organization. The investigators therefore wish to explore users\' views of the device, wearing the device and potential areas for improvement using questionnaires for patients and health care staff and by conducting semi-structured interviews with healthcare staff.
Primary objective To determine the true cardiovascular event rate (defined as at least one of the following criteria: episodes of AF, New Regional Wall Motion Abnormalities, raised cardiac biomarkers hs-troponin T and NT-pro-BNP) versus false cardiovascular events detected by continuous wireless remote monitoring.
Secondary objective To determine patient acceptability and usability for health care professionals of a novel remote monitoring device with automated alert function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Patients admitted or referred to Critical Care (NOTE-AF ICU) | – | Device: Monitoring patients heart rythms with a wireless patch devicePatients admitted or referred to Critical Care |
| Patients admitted to hospital with acute heart failure (NOTE-AF HF) | – | Device: Monitoring patients heart rythms with a wireless patch devicePatients admitted to hospital with acute heart failure |
| Patients admitted to Emergency Services with sepsis or infection (NOTE-AF Sepsis) | – | Device: Monitoring patients heart rythms with a wireless patch devicePatients admitted to Emergency Services with sepsis or infection |
| Patients post upper gastrointestinal surgery (NOTE-AF PULSE-GI) | – | Device: Monitoring patients heart rythms with a wireless patch devicePatients post upper gastrointestinal surgery |
| Patients post vascular interventions (NOTE-AF Vasc) | – | Device: Monitoring patients heart rythms with a wireless patch devicePatients post vascular interventions |
| Patients with acute respiratory failure (NOTE-AF Resp) | – | Device: Monitoring patients heart rythms with a wireless patch devicePatients with acute respiratory failure |
| Patients admitted after acute stroke (NOTE-AF stroke) | – | Device: Monitoring patients heart rythms with a wireless patch devicePatients admitted after acute stroke |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to hospital with a variety of medical conditions
Key inclusion criteria (11 listed)
- Adult patients ≥50 years
- Estimated risk of developing new episodes of AF greater than 5%
- Sinus rhythm at presentation
- One of the following acute conditions:
Key exclusion criteria (6 listed)
- Atrial fibrillation or atrial flutter at the time of screening
- Patients in atrial fibrillation or atrial flutter at time of preoperative assessment or admission to hospital
- Paced cardiac rhythm
- Inability to obtain consent
- Allergy to plaster or silicone
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 |
|---|---|---|
| Monitoring patients heart rythms with a wireless patch deviceThe investigators will collect data in patients at high risk of atrial fibrillation (AF) without a known history of AF to determine clinical predicators of AF. This data will be used to generate virtual digital twins to to predict clinical and subclinical episodes of AF | Device | Patients admitted after acute stroke (NOTE-AF stroke), Patients admitted or referred to Critical Care (NOTE-AF ICU), Patients admitted to Emergency Services with sepsis or infection (NOTE-AF Sepsis), Patients admitted to hospital with acute heart failure (NOTE-AF HF), Patients post upper gastrointestinal surgery (NOTE-AF PULSE-GI), Patients post vascular interventions (NOTE-AF Vasc), Patients with acute respiratory failure (NOTE-AF Resp) |
Primary outcome
To determine the incidence of clinical and subclinical episodes of AF in acutely unwell patients and to generate data for the development and validation of virtual twins and clinical decision support tools.
Time frame: 48 months
1) Number of participants with device detected AF lasting greater than 30 seconds
To determine the incidence of clinical and subclinical episodes of AF in acutely unwell patients and to generate data for the development and validation of virtual twins and clinical decision support tools.
Time frame: 48 months
Number of episodes of AF and duration of each AF episode
18 secondary outcomes
Length of hospital stay
Time frame: 48 months
Hospital readmissions within 90 days
Time frame: 48 months
Recurrence of AF episodes
Time frame: 48 months
Hospital and 90-day Mortality
Time frame: 48 months
Time spent in AF
Time frame: 48 months
Number of AF episodes
Time frame: 48 months
Complications of AF
Time frame: 48 months
High sensitivity Troponin concentrations in patients with AF episodes
Time frame: 48 months
Echocardiographic changes in patients with AF episodes
Time frame: 48 months
mHealth App Usability Questionnaire
Time frame: 48 months
Percentage change of troponin concentrations in patients with and without episodes of AF
Time frame: 48 months
Time wireless continuous vital signs monitoring device is attached
Time frame: 48 months
Number of cardiovascular alerts
Time frame: 48 months
Number of non-cardiovascular alerts
Time frame: 48 months
Number of alerts reflecting clinical changes
Time frame: 48 months
Number of alerts reflecting artefacts or non-clinical events
Time frame: 48 months
RWMA score, atrial size and volume, left ventricular strain rate, standard echocardiographic measurements as per british society of echocardiography recommendations
Time frame: 48 months
Change in inflammatory markers white cell count, C-reactive protein and procalcitonin over time
Time frame: 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Derived from this study: PubMed 41485778Essa H, Johnston B, Lip GYH, Ortega-Martorell S, Williams K, Welters ID; TARGET Consortium. Intelligent monitoring to predict atrial fibrillation (NOTE-AF): clinical study 1 for the 'Health virtual twins for the personalised management of stroke related to atrial fibrillation (TARGET)' project - a protocol for a prospective cohort analysis. BMJ Open. 2026 Jan 3;16(1):e099658. doi: 10.1136/bmjopen-2025-099658.
- Individual participant dataSharing planned: Undecided. Undecided at this point in time
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation New Onset and Postoperative Cardiovascular Complications, run by Liverpool University Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
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 11 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: paused, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Results are not available in the source record.
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?
To determine the incidence of clinical and subclinical episodes of AF in acutely unwell patients and to generate data for the development and validation of virtual twins and clinical decision support tools. (time frame: 48 months). The study lists 2 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 NCT06600620, which also lists 1 linked publication.
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 15 Sep 2025.