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NCT Number: NCT06519747

DETECTion of PeriOperative Atrial Fibrillation After Noncardiac Surgery

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.

Recruiting

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hamilton General Hospital, Hamilton, Ontario, Canada

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About this study

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 monitoring has the potential to enhance POAF detection and improve clinical care in affected patients. Based on this background, the DETECT-POAF study will determine the incidence of clinically important POAF in those receiving up to 14 days of continuous ECG monitoring within 35 days after noncardiac surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cardiac monitoring device

Device

Portable, up to 14 days of monitoring

Primary outcomes

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

    Time frame: Within 35 days of non-cardiac surgery

    The primary outcome is clinically important POAF, defined as:

    • Atrial fibrillation (AF) documented by a 12-lead ECG;
    • Confirmed AF (e.g., rhythm strip) that results in symptoms of angina, heart failure, or symptomatic hypotension;
    • Confirmed AF that requires treatment with a rate controlling drug, antiarrhythmic drug, or electrical cardioversion; or,
    • Confirmed continuous AF episode with a minimum duration of 1 hour.

Secondary outcomes

  1. Incidence of sustained ventricular arrhythmia

    Time frame: Within 35 days of non-cardiac surgery

  2. Incidence of sinus node dysfunction

    Time frame: Within 35 days of non-cardiac surgery

  3. Incidence of high-grade atrioventricular block

    Time frame: Within 35 days of non-cardiac surgery

  4. Incidence of death

    Time frame: Within 35 days of non-cardiac surgery

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

    Time frame: Within 14 days of continuous cardiac monitoring

  6. Incidence of clinically important post-operative atrial fibrillation/atrial flutter detected by clinical monitoring only

    Time frame: Within 35 days of non-cardiac surgery

  7. Incidence of clinically important post-operative atrial fibrillation/atrial flutter define with minimum duration of 6 minutes

    Time frame: Within 35 days of non-cardiac surgery

  8. Incidence of clinically important post-operative atrial fibrillation/atrial flutter detected by study device monitoring only

    Time frame: Within 35 days of non-cardiac surgery

  9. Proportion of participants meeting eligibility criteria for ASPIRE-AF study

    Time frame: Within 35 days of non-cardiac surgery

  10. Multivariate odds ratio of risk factors associated with the occurrence of clinically important POAF

    Time frame: Within 35 days of non-cardiac surgery

    A multivariate logistic regression analysis of age, sex, surgical urgency, type of surgery, vascular disease, chronic kidney disease, and heart failure.

Study contacts

Contact information is provided by the study sponsor or research team.

Kate Brady

CONTACT

[email protected]

Vitheya Thanabalan

CONTACT

[email protected]

+1 905-296-2710

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Official study title

Enhanced DETECTion of PeriOperative Atrial Fibrillation After Noncardiac Surgery with Continuous Electrocardiographic Monitoring

Acronym: DETECT-POAF

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 25, 2024
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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