DETECTion of PeriOperative Atrial Fibrillation After Noncardiac Surgery

NCT ID: NCT06519747

Last Updated: 2024-11-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 750 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2026-12-31

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.

Conditions

Atrial Fibrillation; Atrial Flutter

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study Cohort

Participants will receive up to 14 days of continuous cardiac monitoring

Cardiac monitoring device

Intervention Type: DEVICE

Portable, up to 14 days of monitoring

Interventions

Cardiac monitoring device

Portable, up to 14 days of monitoring

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Population Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Conen, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute

Michael K Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute

Locations

Hamilton General Hospital

Hamilton, Ontario, Canada

Site Status: RECRUITING

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status: NOT_YET_RECRUITING

Juravinski Hospital

Hamilton, Ontario, Canada

Site Status: RECRUITING

London Health Sciences Centre - University Hospital

London, Ontario, Canada

Site Status: NOT_YET_RECRUITING

Niagara Health System - St. Catharine's Site

St. Catharines, Ontario, Canada

Site Status: NOT_YET_RECRUITING

Hôpital Fleurimont du Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Site Status: NOT_YET_RECRUITING

Countries

Canada

Central Contacts

Vitheya Thanabalan

Role: CONTACT

detectpoaf@phri.ca

+1 905-296-2710

Kate Brady

Role: CONTACT

detectpoaf@phri.ca

Facility Contacts

Research Coordinator

Role: primary

gregus@hhsc.ca

905-521-2100 ext. 44156

Mohamed Panju, MD

Role: backup

Vikas Tandon, MD

Role: primary

Ameen Patel, MD

Role: primary

Marko Mrkobrada, MD

Role: primary

Leonard Blair, MD

Role: primary

Félix Ayala-Paredes, MD

Role: primary

Other Identifiers

2023-DETECTPOAF

Identifier Type: -

Identifier Source: org_study_id