DETECTion of PeriOperative Atrial Fibrillation After Noncardiac Surgery

ConditionsAtrial Fibrillation Atrial Flutter

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-120

SponsorPopulation Health Research Institute

About this trial

This is a multicentre prospective cohort study where patients will receive up to 14 days of continuous ECG monitoring by wearing a portable monitoring device, starting within 72 hours after noncardiac surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

an overnight hospital admission after surgery

day surgery that would result in a large enough physiological insult to be able to cause POAF. Procedures excluded include those that are conducted using local anesthesia alone, are less than 30 minutes in duration, and/or are judged to be of low physiologic insult by the local investigator.

Have one of the following high-risk criteria;

age 55-64 years, and having either established cardiovascular disease, recent major vascular surgery, a CHA2DS2-VASc score ≥3, or an elevated postoperative troponin level;

Disqualifiers

History of documented chronic (i.e., non-transient) AF before noncardiac surgery;

Need for long-term systemic anticoagulation;

Ongoing need for long-term dual antiplatelet treatment;

Contraindication to oral anticoagulation;

Trial population

Adults who have undergone noncardiac surgery

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Cardiac monitoring device
Device
Portable, up to 14 days of monitoring

Treatment groups

750 Participants

are divided into 1 treatment group

Group A: Study Cohort1 intervention

Trial outcomes

Primary outcomes

Incidence of clinically important post-operative atrial fibrillation/atrial flutter

The primary outcome is clinically important POAF, defined as: 1. Atrial fibrillation (AF) documented by a 12-lead ECG; 2. Confirmed AF (e.g., rhythm strip) that results in symptoms of angina, heart failure, or symptomatic hypotension; 3. Confirmed AF that requires treatment with a rate controlling drug, antiarrhythmic drug, or electrical cardioversion; or, 4. Confirmed continuous AF episode with a minimum duration of 1 hour.

Time frame