NCT03221777: AFOTS

Atrial Fibrillation Occurring Transiently With Stress (AFOTS)

Completed Last updated 8 November 2023

What this trial tests

trial testing 14 Day ECG Patch (Zio XT Patch, iRhythm Technologies) in Atrial Fibrillation New Onset in 281 participants. Completed in 30 November 2022.

Timeline

1 March 2017

Primary endpoint
31 August 2022

30 November 2022

Quick facts

Lead sponsor	Population Health Research Institute
Status	Completed
Study type	OBSERVATIONAL
Enrollment	281
Start date	1 March 2017
Primary completion	31 August 2022
Estimated completion	30 November 2022
Sites	3 locations across Canada

Drugs / interventions tested

• 14 Day ECG Patch (Zio XT Patch, iRhythm Technologies)

Conditions studied

• Atrial Fibrillation New Onset — all drugs for Atrial Fibrillation New Onset →

Sponsor

Population Health Research Institute

Who can join

18 and older, any sex, with Atrial Fibrillation New Onset. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

1. 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.
2. The risk of recurrent AF after AFOTS will be sufficiently high (\> 80%) to warrant routine initiation of long-term OAC in all cases.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Atrial fibrillation: epidemiology, screening and digital health.
   Linz D, Gawalko M, Betz K, Hendriks JM, et al · · 2024 · cited 230× · PMID 38362546 · DOI 10.1016/j.lanepe.2023.100786
2. Atrial Fibrillation Recurrence in Patients With Transient New-Onset Atrial Fibrillation Detected During Hospitalization for Noncardiac Surgery or Medical Illness : A Matched Cohort Study.
   McIntyre WF, Vadakken ME, Connolly SJ, Mendoza PA, et al · · 2023 · cited 17× · PMID 37782930 · DOI 10.7326/m23-1411
3. Design and rationale of the atrial fibrillation occurring transiently with stress (AFOTS) follow-up cohort study.
   McIntyre WF, Mendoza PA, Belley-Côté EP, Whitlock RP, et al · · 2018 · cited 11× · PMID 30125047 · DOI 10.1002/clc.23053