DETECTion of PeriOperative Atrial Fibrillation After Noncardiac Surgery
Recruiting · NCT06519747 · Observational (researchers observe without assigning treatment) · Lead sponsor: Population Health Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
Cardiac monitoring device
What this trial is about
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.
Who can take part
Age range
18 Years to 120 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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.
- 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;
- Provide written informed consent to participate.
Exclusion criteria
- 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;
- Severe renal insufficiency;
- Severe liver cirrhosis;
- Acute stroke in the past 14 days;
- Underwent cardiac surgery in the past 35 days;
- History of nontraumatic intracranial, intraocular, or spinal bleeding;
- Hemorrhagic disorder or bleeding diathesis;
- Known life expectancy \<1 year due to concomitant disease;
- Women who are pregnant, breastfeeding, or of childbearing potential not taking effective contraception;
- Expected to be non-compliant with follow-up and/or device use;
- Known contact allergy to monitoring device and/or its peripheral components;
- Previously enrolled in DETECT-POAF.
Where it is running
6 locations listed.
- Hamilton General Hospital - Hamilton, Ontario, Canada
- St. Joseph's Healthcare Hamilton - Hamilton, Ontario, Canada
- Juravinski Hospital - Hamilton, Ontario, Canada
- London Health Sciences Centre - University Hospital - London, Ontario, Canada
- Niagara Health System - St. Catharine's Site - St. Catharines, Ontario, Canada
- Hôpital Fleurimont du Centre hospitalier universitaire de Sherbrooke - Sherbrooke, Quebec, Canada