Status:
RECRUITING
DETECTion of PeriOperative Atrial Fibrillation After Noncardiac Surgery
Lead Sponsor:
Population Health Research Institute
Conditions:
Atrial Fibrillation
Atrial Flutter
Eligibility:
All Genders
18-120 years
Brief 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...
Detailed Description
POAF commonly occurs after noncardiac surgery and is associated with adverse long-term outcomes. Despite this, patients with POAF are routinely being missed during clinical practice. Continuous ECG mo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT06519747
Start Date
October 15 2024
End Date
December 31 2026
Last Update
November 7 2024
Active Locations (6)
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1
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
2
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
3
Juravinski Hospital
Hamilton, Ontario, Canada, L8V 1C3
4
London Health Sciences Centre - University Hospital
London, Ontario, Canada, N6A 5A5