Cardiac monitoring device: Portable, up to 14 days of monitoring
Study summary
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
Sex
ALL
Min age
18 Years
Max age
120 Years
Healthy volunteers
No
Inclusion Criteria:
1. Had undergone noncardiac surgery within the past 72 hours and requiring, or expected to require, at least one of the following:
* 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.
2. 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;
* age 65-74 years, and having either established cardiovascular disease, recent major vascular surgery, a CHA2DS2-VASc score ≥2, or an elevated postoperative troponin level; or
* age ≥75 years;
3. Provide written informed consent to participate.
Exclusion Criteria:
1. History of documented chronic (i.e., non-transient) AF before noncardiac surgery;
2. Need for long-term systemic anticoagulation;
3. Ongoing need for long-term dual antiplatelet treatment;
4. Contraindication to oral anticoagulation;
5. Severe renal insufficiency;
6. Severe liver cirrhosis;
7. Acute stroke in the past 14 days;
8. Underwent cardiac surgery in the past 35 days;
9. History of nontraumatic intracranial, intraocular, or spinal bleeding;
10. Hemorrhagic disorder or bleeding diathesis;
11. Known life expectancy \<1 year due to concomitant disease;
12. Women who are pregnant, breastfeeding, or of childbearing potential not taking effective contraception;
13. Expected to be non-compliant with follow-up and/or device use;
14. Known contact allergy to monitoring device and/or its peripheral components;
15. Previously enrolled in DETECT-POAF.
Primary outcome measure(s)
Incidence of clinically important post-operative atrial fibrillation/atrial flutter — Within 35 days of non-cardiac surgery 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.
Trial sites (6)
Facility
City
Region
Status
Hamilton General Hospital
Hamilton
Ontario
Recruiting
St. Joseph's Healthcare Hamilton
Hamilton
Ontario
Not Yet Recruiting
Juravinski Hospital
Hamilton
Ontario
Recruiting
London Health Sciences Centre - University Hospital
London
Ontario
Not Yet Recruiting
Niagara Health System - St. Catharine's Site
St. Catharines
Ontario
Not Yet Recruiting
Hôpital Fleurimont du Centre hospitalier universitaire de Sherbrooke
Sherbrooke
Quebec
Not Yet Recruiting
More Population Health Research Institute trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.