Atrial Fibrillation New OnsetAFOTSNCT03221777
Atrial Fibrillation Occurring Transiently With Stress (AFOTS)
An observational study of Atrial Fibrillation New Onset, run by Population Health Research Institute at 3 sites in Canada.
Trial summary
Rationale Atrial fibrillation (AF) often occurs transiently in the setting of an acute stressor (e.g. medical illness or surgery). Uncertainty exists as to whether AF Occurring Transiently with Stress (AFOTS) is secondary to a reversible precipitant and is benign, or is a first presentation of paroxysmal AF and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation New Onset
- What is being tested?
- 14 Day ECG Patch (Zio XT Patch, iRhythm Technologies)
- How many people
- 281 participants
- Where
- 3 sitesCanada
- Study dates
- 1 Mar 2017to 30 Nov 2022
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients admitted for non-cardiac surgery OR medical Illness, who develop new Atrial Fibrillation Occurring Transiently With Stress (AFOTS) during hospital admission (case group), OR who are exposed to the same stressor, but did not develop AF (control group). All patients will be candidates for OAC therapy as per the Canadian Cardiovascular Society (CCS) AF algorithm [12]. Patients with a history of AF will be excluded from the study.
Who may be able to join
- Cases will be patients without a history of AF who experience new AFOTS during hospital admission for non-cardiac surgery (non-cardiac surgery study) OR medical illness (medical illness study) Controls will be patients who were exposed to a similar stressor but did not develop AF (matched for age within 5 years, sex and stressor).
- All participants will have a CHA2DS2-VaSc score >1 for men, >2 for women.
Who cannot join
- Documented prior history of AF.
- Patients whose rhythm is AF at the time of discharge from hospital
- Patients unsuitable for study follow-up because the patient:
- is unreliable concerning the follow-up schedule
- cannot be contacted by telephone
- has a life expectancy less than one year
Show all 13Show fewer
- Unwilling or unable to participate in the study
- Presence of an implanted pacemaker or defibrillator.
- Documented significant allergy to ECG electrode adhesive.
- Residence in a chronic care facility
- Diagnosed with Ischemic Stroke or Systemic embolism on admission
- Primary cardiac admitting diagnosis (i.e. myocardial infarction, heart failure, pericarditis, arrhythmia)
- Patients with Stage V Chronic Kidney Disease
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Hamilton General Hospital
Hamilton, Ontario
Juravinski Hospital
Hamilton, Ontario
St. Joseph's Health Centre
Hamilton, Ontario
About this study
Official title: Atrial Fibrillation Occurring Transiently With Stress (AFOTS): Understanding the Risks of Recurrent AF. Study in Non-cardiac Surgery and in Medical Illness Patients.
Rationale Atrial fibrillation (AF) often occurs transiently in the setting of an acute stressor (e.g.
medical illness or surgery). Uncertainty exists as to whether AF Occurring Transiently with Stress (AFOTS) is secondary to a reversible precipitant and is benign, or is a first presentation of paroxysmal AF and associated with a risk of stroke. AFOTS is a common occurrence (>40% in some intensive care settings), but there is a lack of evidence to guide its management and guidelines have called for further research in this area. Retrospective data suggest that many patients with AFOTS (>50%) will experience recurrent AF. These estimates were obtained without using sensitive methods for AF detection, which raises the possibility that the true rate of recurrent AF is much higher. As the rate of recurrent AF increases, it becomes increasingly likely that AFOTS is just the first detection of typical "clinical" AF.
Read more
Objective To use a sensitive strategy to determine the rate of recurrent AF among patients who experienced AFOTS following i) non-cardiac surgery OR ii) medical illness, compared to matched controls.
Methods Two multi-centre, 138-patient, observational cohorts. AFOTS patients will have new AF, documented by 12-Lead ECG or surface monitoring, during hospitalization for non- cardiac surgery (Cohort 1) or medical illness (Cohort 2).
Controls will be patients without a history of AF who are matched for age (within 5 years), sex and exposure to stressor. Participants will wear a 14-day ECG monitor at 1 and 6 months after discharge. The endpoint is detection of AF.
Impact
If the incidence of AF after AFOTS is >80%, clinicians could be advised to treat AFOTS like "clinical" AF and initiate anticoagulation according to guidelines. Otherwise, a strategy of surveillance for AF would be advised.
Hypothesis
- Patients who experience AFOTS will have a higher future incidence of AF and of stroke compared to patients exposed to a similar stressor but who did not develop AF.
- The risk of recurrent AF after AFOTS will be sufficiently high (> 80%) to warrant routine initiation of long-term OAC in all cases.
- Conditions
- Atrial Fibrillation New Onset
- Being tested
- 14 Day ECG Patch (Zio XT Patch, iRhythm Technologies)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14 Day ECG Patch (Zio XT Patch, iRhythm Technologies)Diagnostic test
The ZIO XT Patch (http://www.irhythmtech.com/zio-solution/zio-patch/) is an ultra-portable wearable adhesive patch monitor that provides continuous single-lead ECG recording for up to 14 days. It has been cleared by the FDA for arrhythmia detection and is in current clinical use in the U.S.[87]. It will be used in this study under an investigational testing authorization by Health Canada. The ZIO XT Patch is a single-use device worn over the left pectoral region with a skin adhesive (Figure 4). Its small, lightweight, water-resistant, patch-based design has advantages for patients compared with traditional ECG screening methods (e.g. Holter, event loop recorders, mobile outpatient telemetry systems), which are all more cumbersome and require detachable wired leads, two or more removable skin contact electrodes, plus separate recording units (+/- smartphone attachment).
| Study group | Role | What they receive |
|---|---|---|
| AFOTS - Medical Illness Cases | Patients who have AF detected for the first time in the setting of an acute non-cardiovascular medical (i.e. non-surgical ).
14 day patch ECG monitor at 1 month and 6 months after hospital discharge Receives: Diagnostic Test: 14 Day ECG Patch (Zio XT Patch, iRhythm Technologies) | |
| Medical Illness Controls | Patients without a history of AF who are hospitalized for an acute non-cardiovascular medical (i.e. non-surgical) and do not have AF detected.
14 day patch ECG monitor at 1 month and 6 months after hospital discharge Receives: Diagnostic Test: 14 Day ECG Patch (Zio XT Patch, iRhythm Technologies) | |
| AFOTS - Non-cardiac surgery Cases | Patients who have AF detected for the first time following non-cardiac surgery.
14 day patch ECG monitor at 1 month and 6 months after hospital discharge Receives: Diagnostic Test: 14 Day ECG Patch (Zio XT Patch, iRhythm Technologies) | |
| Non-cardiac Surgery Controls | Patients without a history of AF who are hospitalized after non-cardiac surgery and do not have AF detected.
14 day patch ECG monitor at 1 month and 6 months after hospital discharge Receives: Diagnostic Test: 14 Day ECG Patch (Zio XT Patch, iRhythm Technologies) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial Fibrillation >/=30 s
Measured: 1 year
Secondary outcomes (13)
Time to Atrial Fibrillation
Among AFOTS patients with the primary endpoint detected by the ECG patch monitor: time to first detection of AF >30 s.
Measured: 1 year
Daily and total AF burden
Among AFOTS patients with the primary endpoint detected by the ECG patch monitor: daily and total AF burden.
Measured: 1 year
Average duration per AF episode
Among AFOTS patients with the primary endpoint detected by the ECG patch monitor: average duration per AF episode
Measured: 1 year
Other durations of Atrial Fibrillation
Among AFOTS patients, occurence of any AF episode lasting ≥30 seconds, ≥30 seconds to 5 minutes, >5 hours, and >24 hours (to facilitate comparison with other studies in the literature).( within 12 months post-enrolment)
Measured: 1 year
Atrial Fibrillation at 1 and 6 months
Detection of the primary outcome at 1 and 6 months post enrolment.
Measured: 1 and 6 months
Other clinical outcomes
Incidence of Clinical outcome events within 12 months post-enrolment (death, stroke, bleeding, embolism and hospitalization for heart failure or myocardial infarction), physician visits, hospitalizations and medication prescriptions.
Measured: 1 year
OAC Use
Oral anticoagulant therapy use
Measured: 1 year
Cost-effectiveness
Cost-effectiveness (cost per life year saved)
Measured: 1 year
Cost-utility
cost-utility (cost per quality adjusted life year (QALY) gained) of AF screening
Measured: 1 year
Patient adherence
Patient adherence with the monitoring devices (defined as the average number of monitoring days completed and reasons for non-adherence)
Measured: 1 year
Patient satisfaction
patient satisfaction with the monitoring devices (as measured by user satisfaction surveys),
Measured: 1 year
Sensitivity and Specificity
Estimated sensitivity, specificity of non-patch ECG monitoring(i.e. monitoring done outside of the study protocol), with ZioXT ECG patch monitor as the gold standard
Measured: 1 year
Other arrhythmias
Incidence of Detection of other potentially clinically important non-AF arrhythmias: atrial tachycardia, pause >3 seconds, high-grade atrioventricular block (Mobitz type II or third-degree AV block), ventricular tachycardia, polymorphic ventricular tachycardia/ventricular fibrillation. ( within 12 months post-enrolment)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start1 Mar 2017
- Primary completion31 Aug 2022
- Study completion30 Nov 2022
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
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cardiovascular Society, Canadian Stroke Prevention Intervention Network
- Responsible party
- Principal investigator, William McIntyre, Population Health Research Institute
- Investigators
- Jeff Healey, Principal investigator, Population Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221777
- Sponsor's protocol ID
- AFOTS
- Acronym
- AFOTS
- Status last verified
- Nov 2023
- First submitted
- 30 Jun 2017
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
McIntyre WF, Vadakken ME, Connolly SJ, Mendoza PA, Lengyel AP, Rai AS, Latendresse NR, Grinvalds AJ, Ramasundarahettige C, Acosta JG, Um KJ, Roberts JD, Conen D, Wong JA, Devereaux PJ, Belley-Cote EP, Whitlock RP, Healey JS. Atrial Fibrillation Recurrence in Patients With Transient New-Onset Atrial Fibrillation Detected During Hospitalization for Noncardiac Surgery or Medical Illness : A Matched Cohort Study. Ann Intern Med. 2023 Oct;176(10):1299-1307. doi: 10.7326/M23-1411. Epub 2023 Oct 3.
PubMed 37782930
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation Occurring Transiently With Stress (AFOTS): Understanding the Risks of Recurrent AF. Study in Non-cardiac Surgery and in Medical Illness Patients.
- ClinicalTrials.gov ID
- NCT03221777
- Acronym / sponsor ID
- AFOTS / AFOTS
- Conditions
- Atrial Fibrillation New Onset
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Cardiovascular Society, Canadian Stroke Prevention Intervention Network
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 19 Jul 2017 (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.
Rationale Atrial fibrillation (AF) often occurs transiently in the setting of an acute stressor (e.g.
medical illness or surgery). Uncertainty exists as to whether AF Occurring Transiently with Stress (AFOTS) is secondary to a reversible precipitant and is benign, or is a first presentation of paroxysmal AF and associated with a risk of stroke. AFOTS is a common occurrence (>40% in some intensive care settings), but there is a lack of evidence to guide its management and guidelines have called for further research in this area. Retrospective data suggest that many patients with AFOTS (>50%) will experience recurrent AF. These estimates were obtained without using sensitive methods for AF detection, which raises the possibility that the true rate of recurrent AF is much higher. As the rate of recurrent AF increases, it becomes increasingly likely that AFOTS is just the first detection of typical "clinical" AF.
Objective To use a sensitive strategy to determine the rate of recurrent AF among patients who experienced AFOTS following i) non-cardiac surgery OR ii) medical illness, compared to matched controls.
Methods Two multi-centre, 138-patient, observational cohorts. AFOTS patients will have new AF, documented by 12-Lead ECG or surface monitoring, during hospitalization for non- cardiac surgery (Cohort 1) or medical illness (Cohort 2).
Controls will be patients without a history of AF who are matched for age (within 5 years), sex and exposure to stressor. Participants will wear a 14-day ECG monitor at 1 and 6 months after discharge. The endpoint is detection of AF.
Impact
If the incidence of AF after AFOTS is >80%, clinicians could be advised to treat AFOTS like "clinical" AF and initiate anticoagulation according to guidelines. Otherwise, a strategy of surveillance for AF would be advised.
Hypothesis
- Patients who experience AFOTS will have a higher future incidence of AF and of stroke compared to patients exposed to a similar stressor but who did not develop AF.
- The risk of recurrent AF after AFOTS will be sufficiently high (> 80%) to warrant routine initiation of long-term OAC in all cases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AFOTS - Medical Illness Cases | – | Diagnostic Test: 14 Day ECG Patch (Zio XT Patch, iRhythm Technologies)Patients who have AF detected for the first time in the setting of an acute non-cardiovascular medical (i.e. non-surgical ). 14 day patch ECG monitor at 1 month and 6 months after hospital discharge |
| Medical Illness Controls | – | Diagnostic Test: 14 Day ECG Patch (Zio XT Patch, iRhythm Technologies)Patients without a history of AF who are hospitalized for an acute non-cardiovascular medical (i.e. non-surgical) and do not have AF detected. 14 day patch ECG monitor at 1 month and 6 months after hospital discharge |
| AFOTS - Non-cardiac surgery Cases | – | Diagnostic Test: 14 Day ECG Patch (Zio XT Patch, iRhythm Technologies)Patients who have AF detected for the first time following non-cardiac surgery. 14 day patch ECG monitor at 1 month and 6 months after hospital discharge |
| Non-cardiac Surgery Controls | – | Diagnostic Test: 14 Day ECG Patch (Zio XT Patch, iRhythm Technologies)Patients without a history of AF who are hospitalized after non-cardiac surgery and do not have AF detected. 14 day patch ECG monitor at 1 month and 6 months after hospital discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients admitted for non-cardiac surgery OR medical Illness, who develop new Atrial Fibrillation Occurring Transiently With Stress (AFOTS) during hospital admission (case group), OR who are exposed to the same stressor, but did not develop AF (control group). All patients will be candidates for OAC therapy as per the Canadian Cardiovascular Society (CCS) AF algorithm [12]. Patients with a history of AF will be excluded from the study.
Key inclusion criteria (2 listed)
- Cases will be patients without a history of AF who experience new AFOTS during hospital admission for non-cardiac surgery (non-cardiac surgery study) OR medical illness (medical illness study) Controls will be patients who were exposed to a similar stressor but did not develop AF (matched for age within 5 years, sex and stressor).
- All participants will have a CHA2DS2-VaSc score >1 for men, >2 for women.
Key exclusion criteria (13 listed)
- Documented prior history of AF.
- Patients whose rhythm is AF at the time of discharge from hospital
- Patients unsuitable for study follow-up because the patient:
- Unwilling or unable to participate in the study
- Presence of an implanted pacemaker or defibrillator.
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 |
|---|---|---|
| 14 Day ECG Patch (Zio XT Patch, iRhythm Technologies)The ZIO XT Patch (http://www.irhythmtech.com/zio-solution/zio-patch/) is an ultra-portable wearable adhesive patch monitor that provides continuous single-lead ECG recording for up to 14 days. It has been cleared by the FDA for arrhythmia detection and is in current clinical use in the U.S.[87]. It will be used in this study under an investigational testing authorization by Health Canada. The ZIO XT Patch is a single-use device worn over the left pectoral region with a skin adhesive (Figure 4). Its small, lightweight, water-resistant, patch-based design has advantages for patients compared with traditional ECG screening methods (e.g. Holter, event loop recorders, mobile outpatient telemetry systems), which are all more cumbersome and require detachable wired leads, two or more removable skin contact electrodes, plus separate recording units (+/- smartphone attachment). | Diagnostic test | AFOTS - Medical Illness Cases, AFOTS - Non-cardiac surgery Cases, Medical Illness Controls, Non-cardiac Surgery Controls |
Primary outcome
Atrial Fibrillation >/=30 s
Time frame: 1 year
13 secondary outcomes
Time to Atrial Fibrillation
Time frame: 1 year
Daily and total AF burden
Time frame: 1 year
Average duration per AF episode
Time frame: 1 year
Other durations of Atrial Fibrillation
Time frame: 1 year
Atrial Fibrillation at 1 and 6 months
Time frame: 1 and 6 months
Other clinical outcomes
Time frame: 1 year
OAC Use
Time frame: 1 year
Cost-effectiveness
Time frame: 1 year
Cost-utility
Time frame: 1 year
Patient adherence
Time frame: 1 year
Patient satisfaction
Time frame: 1 year
Sensitivity and Specificity
Time frame: 1 year
Other arrhythmias
Time frame: 1 year
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 8 Nov 2023.
- Results publication: PubMed 37782930McIntyre WF, Vadakken ME, Connolly SJ, Mendoza PA, Lengyel AP, Rai AS, Latendresse NR, Grinvalds AJ, Ramasundarahettige C, Acosta JG, Um KJ, Roberts JD, Conen D, Wong JA, Devereaux PJ, Belley-Cote EP, Whitlock RP, Healey JS. Atrial Fibrillation Recurrence in Patients With Transient New-Onset Atrial Fibrillation Detected During Hospitalization for Noncardiac Surgery or Medical Illness : A Matched Cohort Study. Ann Intern Med. 2023 Oct;176(10):1299-1307. doi: 10.7326/M23-1411. Epub 2023 Oct 3.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation New Onset
Recruiting
BoxX-NoAF Clinical Trial
Post Operative Atrial Fibrillation, Atrial Fibrillation, Postoperative
Recruiting
The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block
Left Bundle Branch Area Pacing, Right Ventricular Pacing
RecruitingPhase 3
Short Term Anti-aRrhythmic Therapy for Post-Operative AF in Cardiac Surgery Patients Pilot Trial
Atrial Fibrillation New Onset
Not yet recruiting
The Effect of Ligament of Marshall Excision During Minimally Invasive Cardiac Surgery-Coronary Artery Bypass Grafting (MICS-CABG) on the Prevention of Postoperative New-Onset Atrial Fibrillation: A Multicenter, Prospective, Randomized, Triple-Blinded Study
Postoperative Atrial Fibrillation
Not yet recruitingObservational study
Clinical Validation of SMD-AFECG for Predicting New-Onset Atrial Fibrillation Within 2 Hours Using Single-Lead ECG Data
Atrial Fibrillation (AF), Atrial Fibrillation New Onset
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.
Jeff Healey principal investigator
Population Health Research Institute
3 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, run by Population Health Research Institute at 3 sites in Canada.
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 2 inclusion and 13 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 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
Atrial Fibrillation >/=30 s (time frame: 1 year). 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 NCT03221777, 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 8 Nov 2023.