DETECTion of PeriOperative Atrial Fibrillation After Noncardiac Surgery

Recruiting

• Conditions: Atrial Fibrillation; Atrial Flutter
• Interventions: Device: Cardiac monitoring device

• Registration Number: NCT06519747
• Lead Sponsor: Population Health Research Institute

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 surgery.

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 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.

Study Timeline

• Study First Submitted: 2024-07-09
• Study First Submitted QC: 2024-07-19
• Study First Posted: 2024-07-25
• Study Start: 2024-10-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07
• Primary Completion: 2026-08-15
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 750

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Cohort	Cardiac monitoring device	Participants will receive up to 14 days of continuous cardiac monitoring

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Incidence of death	Within 35 days of non-cardiac surgery
Incidence of clinically important post-operative atrial fibrillation/atrial flutter detected by study device monitoring only	Within 35 days of non-cardiac surgery
Proportion of participants meeting eligibility criteria for ASPIRE-AF study	Within 35 days of non-cardiac surgery
Incidence of sustained ventricular arrhythmia	Within 35 days of non-cardiac surgery
Incidence of sinus node dysfunction	Within 35 days of non-cardiac surgery
Incidence of high-grade atrioventricular block	Within 35 days of non-cardiac surgery
Incidence of clinically important post-operative atrial fibrillation/atrial flutter detected by clinical monitoring only	Within 35 days of non-cardiac surgery
Incidence of clinically important post-operative atrial fibrillation/atrial flutter define with minimum duration of 6 minutes	Within 35 days of non-cardiac surgery
Incidence of clinically important post-operative atrial fibrillation/atrial flutter	Within 14 days of continuous cardiac monitoring
Multivariate odds ratio of risk factors associated with the occurrence of clinically important POAF	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.

Trial Locations

Locations (6)

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