Atrial Fibrillation New OnsetTrAFFICNCT05229211
Tracking Atrial Fibrillation After Intensive Care Admission
An observational study of Atrial Fibrillation New Onset and New Onset Atrial Fibrillation, run by University of Oxford at 1 site in United Kingdom.
Trial summary
Atrial fibrillation (AF) is a heart problem that causes an irregular heartbeat. It can cause the heart to beat more rapidly and reduce the heart's ability to pump blood around the body efficiently, causing heart failure. It also increases the risk of blood clots forming inside the heart. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Atrial Fibrillation New Onset, New Onset Atrial Fibrillation, Atrial Fibrillation
- What is being tested?
- Cardiac monitoring
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2022to 31 Dec 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: Patients admitted to an intensive care unit for more than twenty four hours who were not known to have atrial fibrillation prior to admission.
Who may be able to join
- Willing and able to give informed consent for participation in the study, or favourable consultee advice for adults lacking capacity
- Male or Female,
- aged 16 years or above.
- Admitted to intensive care for >24 hours
- New onset atrial fibrillation as confirmed by 12 lead ECG-
Who cannot join
- History of atrial fibrillation
- Unable to undergo cardiac monitoring
- Previously included in the study
- Not anticipated by treating consultant to survive to ICU discharge (withdrawal or limitation of medical treatment at time of screening)
- Contraindication to anticoagulation
- Unable to wear the device for the prescribed monitoring period
- Implanted neurostimulator, as this may disrupt the ECG recording
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford University Hospitals Trust
Oxford, Oxfordshire, OX3 9DU
About this study
Atrial fibrillation (AF) is a heart problem that causes an irregular heartbeat. It can cause the heart to beat more rapidly and reduce the heart's ability to pump blood around the body efficiently, causing heart failure. It also increases the risk of blood clots forming inside the heart. These clots may then be pumped out of the heart, through the blood vessels, to other parts of the body. This can cause strokes if the clots spread to the brain.
AF is a common problem outside an Intensive Care Unit (ICU), where treatment is based on good, evidence-based guidelines designed to reduce the risk of problems like heart failure or strokes. Around 10% of patients treated in ICU develop atrial fibrillation as a complication of their underlying illness. Some patients will recover their normal heart rhythm before leaving the ICU, often with the help of some medical treatments. It is not known whether these patients will get AF again after leaving the ICU, or when this is likely to happen. It is also unknown whether patients who avoid AF whilst on the ICU may still be at high risk of developing it after they leave.
Read more
This study will identify patients on the ICU who have no previous record of atrial fibrillation. These patients will be monitored whilst on the ICU to identify those who develop AF. Those patients who develop new onset AF will be monitored on the ward after leaving the ICU to see which patients have AF at this point. The heart monitoring will be repeated once the patients leave hospital, again to identify whether they have atrial fibrillation.
Some studies suggest that AF during critical illness causes a long-term risk of recurrent AF and AF associated complications such as heart failure, stroke, and death. To understand how to minimise these risks in intensive care patients, we need to know how which patients who develop atrial fibrillation whilst in an ICU go on to have recurrent atrial fibrillation in hospital and in the community. These patients may benefit from interventions to reduce long term adverse events such as anticoagulation to reduce stroke risk.
Read the detailed description
The study aims to determine whether it is feasible to screen patients to detect atrial fibrillation after treatment on an intensive care unit. Patients who develop new onset AF in ICU who have no history of atrial fibrillation prior to ICU admission will be included. These patients will be monitored for atrial fibrillation on the ward post ICU discharge (for 14 days or until hospital discharge), and then again at 3 months post hospital discharge (for 7 days), when they attend the routine post ICU follow up clinic.
In the ICU, this study cohort of patients will be monitored continuously to detect atrial fibrillation. If atrial fibrillation is suspected, this will be confirmed by independent review of a 12-lead ECG. On the ward, post ICU discharge patients will be given a chest patch for continuous cardiac rhythm monitoring designed to detect arrhythmia, which they will wear for 7 days, before a second patch is used for a further 7 days or until hospital discharge, whichever is shortest in duration.
Data relating to past medical history, history of illness requiring ICU admission, subsequent events post ICU discharge and complications post-hospital discharge including hospital readmissions will be collected via hospital records and by patient interview at the follow up clinic.
Patients will attend the ICU follow up clinic at 3 months post hospital discharge. At this time, they will be provided with a new chest patch from the same manufacturer, which they will wear for 7 days.
The primary aim will be to demonstrate the feasibility of monitoring patients for AF occurrence post ICU discharge using a wearable patch device.
Secondary aims will be to identify the proportion of patients who develop NOAF (New onset atrial fibrillation) in ICU who go on to have AF post discharge, as well as documenting the stroke risk, mortality and length of hospital stay in this patient group. This study will guide the design of a larger study investigating AF occurrence and stroke risk in patients post ICU discharge.
Exploratory objectives include to validate a newly designed AF detection algorithm.
Objective 1: Validation of a new state-of-the-art machine learning algorithm against the manufactured-approved AF detection algorithm and three best-in-class algorithms.
Objective 2: Identify subgroups of patients that are at increased risk of adverse outcomes of new onset atrial fibrillation in ICU compared to those who are not.
- Being tested
- Cardiac monitoring
- Keywords
- Critical illness, Intensive care, Atrial fibrillation, Outcomes
- Medical subject headings
- Atrial Fibrillation, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac monitoringDevice
Also called VitalConnect patch
Continuous ECG monitoring via VitalConnect patch worn on the chest.
| Study group | Role | What they receive |
|---|---|---|
| New Onset Atrial Fibrillation | Patients admitted to an adult intensive care unit for more than 24 hours who develop new onset atrial fibrillation during their ICU admission will be included. After discharge from ICU patients will undergo continuous ECG monitoring via VitalConnect patch for 14 days or until hospital discharge, whichever is shortest. They will undergo a further 7 days of continuous ECG monitoring via VitalConnect patch as an outpatient at 3 months post hospital discharge. Receives: Device: Cardiac monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eligible patients who are willing to participate in the study
Measured: 3 months post hospital discharge
Proportion of patients who are compliant with the study protocol
Measured: 3 months post hospital discharge
Proportion of patients lost to follow up
Measured: 3 months post hospital discharge
Secondary outcomes (9)
Proportion of patients who are in AF post ICU discharge in hospital.
Measured: 14 days post ICU hospital discharge
Proportion of patients who are in AF at 3 months post hospital discharge
Measured: 3 months post hospital discharge
Proportion of patients who develop NOAF in ICU who develop stroke or TIA post ICU discharge
Measured: 14 days post ICU discharge
Proportion of patients who develop NOAF in ICU who develop stroke or TIA post hospital discharge
Measured: 3 months post hospital discharge
Difference in hospital length of stay in patients who develop atrial fibrillation after ICU discharge compared to patients who do not.
To compare patients who develop NOAF in ICU and have recurrent AF in hospital with those who do not have recurrent AF in hospital
Measured: Follow up patient appointment at 3 months post hospital discharge.
Difference in number of ICU readmissions in patients who develop atrial fibrillation after ICU discharge compared to those who do not.
To compare patients who develop NOAF in ICU and have recurrent AF in hospital with those who do not have recurrent AF in hospital
Measured: Follow up patient appointment at 3 months post hospital discharge.
Difference in mortality in patients who develop atrial fibrillation after ICU discharge compared to those who do not.
To compare patients who develop NOAF in ICU and have recurrent AF in hospital and/or post hospital discharge with those who do not have recurrent AF.
Measured: From ICU discharge to follow up patient appointment at 3 months post hospital discharge.
Proportion of patients who develop NOAF in ICU who develop bleeding complications post ICU discharge.
Major and minor bleeding episodes as defined by the International Society on Thrombosis and Haemostasis Criteria.
Measured: From ICU discharge to 14 days post ICU discharge
Proportion of patients who develop NOAF in ICU who develop bleeding complications post hospital discharge.
Major and minor bleeding episodes as defined by the International Society on Thrombosis and Haemostasis Criteria.
Measured: 3 months post hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start1 Feb 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation New OnsetStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229211
- Sponsor's protocol ID
- PID291237
- Acronym
- TrAFFIC
- Status last verified
- May 2026
- First submitted
- 16 Dec 2021
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracking Atrial Fibrillation After Intensive Care Admission
- ClinicalTrials.gov ID
- NCT05229211
- Acronym / sponsor ID
- TrAFFIC / PID291237
- Keywords
- Critical illness, Intensive care, Atrial fibrillation, Outcomes
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Feb 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.
Atrial fibrillation (AF) is a heart problem that causes an irregular heartbeat. It can cause the heart to beat more rapidly and reduce the heart's ability to pump blood around the body efficiently, causing heart failure. It also increases the risk of blood clots forming inside the heart. These clots may then be pumped out of the heart, through the blood vessels, to other parts of the body. This can cause strokes if the clots spread to the brain.
AF is a common problem outside an Intensive Care Unit (ICU), where treatment is based on good, evidence-based guidelines designed to reduce the risk of problems like heart failure or strokes. Around 10% of patients treated in ICU develop atrial fibrillation as a complication of their underlying illness. Some patients will recover their normal heart rhythm before leaving the ICU, often with the help of some medical treatments. It is not known whether these patients will get AF again after leaving the ICU, or when this is likely to happen. It is also unknown whether patients who avoid AF whilst on the ICU may still be at high risk of developing it after they leave.
This study will identify patients on the ICU who have no previous record of atrial fibrillation. These patients will be monitored whilst on the ICU to identify those who develop AF. Those patients who develop new onset AF will be monitored on the ward after leaving the ICU to see which patients have AF at this point. The heart monitoring will be repeated once the patients leave hospital, again to identify whether they have atrial fibrillation.
Some studies suggest that AF during critical illness causes a long-term risk of recurrent AF and AF associated complications such as heart failure, stroke, and death. To understand how to minimise these risks in intensive care patients, we need to know how which patients who develop atrial fibrillation whilst in an ICU go on to have recurrent atrial fibrillation in hospital and in the community. These patients may benefit from interventions to reduce long term adverse events such as anticoagulation to reduce stroke risk.
Detailed description
The study aims to determine whether it is feasible to screen patients to detect atrial fibrillation after treatment on an intensive care unit. Patients who develop new onset AF in ICU who have no history of atrial fibrillation prior to ICU admission will be included. These patients will be monitored for atrial fibrillation on the ward post ICU discharge (for 14 days or until hospital discharge), and then again at 3 months post hospital discharge (for 7 days), when they attend the routine post ICU follow up clinic.
In the ICU, this study cohort of patients will be monitored continuously to detect atrial fibrillation. If atrial fibrillation is suspected, this will be confirmed by independent review of a 12-lead ECG. On the ward, post ICU discharge patients will be given a chest patch for continuous cardiac rhythm monitoring designed to detect arrhythmia, which they will wear for 7 days, before a second patch is used for a further 7 days or until hospital discharge, whichever is shortest in duration.
Data relating to past medical history, history of illness requiring ICU admission, subsequent events post ICU discharge and complications post-hospital discharge including hospital readmissions will be collected via hospital records and by patient interview at the follow up clinic.
Patients will attend the ICU follow up clinic at 3 months post hospital discharge. At this time, they will be provided with a new chest patch from the same manufacturer, which they will wear for 7 days.
The primary aim will be to demonstrate the feasibility of monitoring patients for AF occurrence post ICU discharge using a wearable patch device.
Secondary aims will be to identify the proportion of patients who develop NOAF (New onset atrial fibrillation) in ICU who go on to have AF post discharge, as well as documenting the stroke risk, mortality and length of hospital stay in this patient group. This study will guide the design of a larger study investigating AF occurrence and stroke risk in patients post ICU discharge.
Exploratory objectives include to validate a newly designed AF detection algorithm.
Objective 1: Validation of a new state-of-the-art machine learning algorithm against the manufactured-approved AF detection algorithm and three best-in-class algorithms.
Objective 2: Identify subgroups of patients that are at increased risk of adverse outcomes of new onset atrial fibrillation in ICU compared to those who are not.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New Onset Atrial Fibrillation | – | Device: Cardiac monitoringPatients admitted to an adult intensive care unit for more than 24 hours who develop new onset atrial fibrillation during their ICU admission will be included. After discharge from ICU patients will undergo continuous ECG monitoring via VitalConnect patch for 14 days or until hospital discharge, whichever is shortest. They will undergo a further 7 days of continuous ECG monitoring via VitalConnect patch as an outpatient at 3 months post hospital discharge. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted to an intensive care unit for more than twenty four hours who were not known to have atrial fibrillation prior to admission.
Key inclusion criteria (5 listed)
- Willing and able to give informed consent for participation in the study, or favourable consultee advice for adults lacking capacity
- Male or Female,
- aged 16 years or above.
- Admitted to intensive care for >24 hours
- New onset atrial fibrillation as confirmed by 12 lead ECG-
Key exclusion criteria (7 listed)
- History of atrial fibrillation
- Unable to undergo cardiac monitoring
- Previously included in the study
- Not anticipated by treating consultant to survive to ICU discharge (withdrawal or limitation of medical treatment at time of screening)
- Contraindication to anticoagulation
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 |
|---|---|---|
| Cardiac monitoringAlso: VitalConnect patchContinuous ECG monitoring via VitalConnect patch worn on the chest. | Device | New Onset Atrial Fibrillation |
Primary outcome
Proportion of eligible patients who are willing to participate in the study
Time frame: 3 months post hospital discharge
Proportion of patients who are compliant with the study protocol
Time frame: 3 months post hospital discharge
Proportion of patients lost to follow up
Time frame: 3 months post hospital discharge
9 secondary outcomes
Proportion of patients who are in AF post ICU discharge in hospital.
Time frame: 14 days post ICU hospital discharge
Proportion of patients who are in AF at 3 months post hospital discharge
Time frame: 3 months post hospital discharge
Proportion of patients who develop NOAF in ICU who develop stroke or TIA post ICU discharge
Time frame: 14 days post ICU discharge
Proportion of patients who develop NOAF in ICU who develop stroke or TIA post hospital discharge
Time frame: 3 months post hospital discharge
Difference in hospital length of stay in patients who develop atrial fibrillation after ICU discharge compared to patients who do not.
Time frame: Follow up patient appointment at 3 months post hospital discharge.
Difference in number of ICU readmissions in patients who develop atrial fibrillation after ICU discharge compared to those who do not.
Time frame: Follow up patient appointment at 3 months post hospital discharge.
Difference in mortality in patients who develop atrial fibrillation after ICU discharge compared to those who do not.
Time frame: From ICU discharge to follow up patient appointment at 3 months post hospital discharge.
Proportion of patients who develop NOAF in ICU who develop bleeding complications post ICU discharge.
Time frame: From ICU discharge to 14 days post ICU discharge
Proportion of patients who develop NOAF in ICU who develop bleeding complications post hospital discharge.
Time frame: 3 months post hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Atrial Fibrillation New Onset and New Onset Atrial Fibrillation, run by University of Oxford at 1 site 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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 19 May 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of eligible patients who are willing to participate in the study (time frame: 3 months post hospital discharge). 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?
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 19 May 2026.