DETECTion of PeriOperative Atrial Fibrillation After Noncardiac Surgery (DETECT-POAF)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Atrial Flutter
• Intervention / Treatment: Device: Cardiac monitoring device

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 Type: Observational
• Enrollment (Estimated): 750

Contacts and Locations

• Study Contact: Name: Vitheya Thanabalan; Phone Number: +1 905-296-2710; Email: detectpoaf@phri.ca
• Study Contact Backup: Name: Kate Brady; Email: detectpoaf@phri.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Recruiting
      • Hamilton General Hospital
      • Contact: Research Coordinator; Phone Number: 44156 905-521-2100; Email: gregus@hhsc.ca
      • Contact: Mohamed Panju, MD
    • Hamilton, Ontario, Canada, L8V 1C3
      • Recruiting
      • Juravinski Hospital
      • Contact: Ameen Patel, MD
    • Hamilton, Ontario, Canada, L8N 4A6
      • Not yet recruiting
      • St. Joseph's Healthcare Hamilton
      • Contact: Vikas Tandon, MD
    • London, Ontario, Canada, N6A 5A5
      • Not yet recruiting
      • London Health Sciences Centre - University Hospital
      • Contact: Marko Mrkobrada, MD
    • St. Catharines, Ontario, Canada, L2S 0A9
      • Not yet recruiting
      • Niagara Health System - St. Catharine's Site
      • Contact: Leonard Blair, MD
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5H3
      • Not yet recruiting
      • Hôpital Fleurimont du Centre hospitalier universitaire de Sherbrooke
      • Contact: Felix Ayala-Paredes, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults who have undergone noncardiac surgery

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study Cohort; Participants will receive up to 14 days of continuous cardiac monitoring	Device: Cardiac monitoring device; Portable, up to 14 days of monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of clinically important post-operative atrial fibrillation/atrial flutter	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.	Within 35 days of non-cardiac surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 death		Within 35 days of non-cardiac surgery
Incidence of clinically important post-operative atrial fibrillation/atrial flutter		Within 14 days of continuous cardiac monitoring
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 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
Multivariate odds ratio of risk factors associated with the occurrence of clinically important POAF	A multivariate logistic regression analysis of age, sex, surgical urgency, type of surgery, vascular disease, chronic kidney disease, and heart failure.	Within 35 days of non-cardiac surgery

Collaborators and Investigators

• Sponsor: Population Health Research Institute
• Investigators: Principal Investigator: David Conen, MD, MPH, Population Health Research Institute; Principal Investigator: Michael K Wang, MD, Population Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 9, 2024
• First Submitted That Met QC Criteria: July 19, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Estimated): November 7, 2024
• Last Update Submitted That Met QC Criteria: November 5, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Cardiac monitoring
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Atrial Flutter
• Other Study ID Numbers: 2023-DETECTPOAF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No