Monitoring heart rhythm after noncardiac surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter prospective cohort study aims to detect perioperative atrial fibrillation (POAF) by utilizing continuous ECG monitoring for up to 14 days in patients who have undergone noncardiac surgery. Patients will wear a portable monitoring device starting within 72 hours post-surgery to identify the incidence of clinically significant POAF. The study seeks to address the common oversight of POAF in clinical practice, which can lead to adverse long-term outcomes. By enhancing detection through continuous monitoring, the study aims to improve clinical care for affected patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hamilton General Hospital
  Hamilton, Ontario, Canada Recruiting
• Juravinski Hospital
  Hamilton, Ontario, Canada Recruiting
• St. Joseph's Healthcare Hamilton
  Hamilton, Ontario, Canada Not yet recruiting
• London Health Sciences Centre - University Hospital
  London, Ontario, Canada Not yet recruiting
• Niagara Health System - St. Catharine's Site
  St. Catharines, Ontario, Canada Not yet recruiting
• Hôpital Fleurimont du Centre hospitalier universitaire de Sherbrooke
  Sherbrooke, Quebec, Canada Not yet recruiting

Study contacts

• Principal investigator: David Conen, MD, MPH — Population Health Research Institute
• Study coordinator: Vitheya Thanabalan
• Email: detectpoaf@phri.ca
• Phone: +1 905-296-2710

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.