Recruiting

Observational Study

Sponsor:

Population Health Research Institute

Code:

NCT06519747

Conditions

Atrial Fibrillation

Atrial Flutter

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Cardiac monitoring device

Study Details

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.

Conditions

Atrial Fibrillation

Atrial Flutter

Study ID

NCT06519747

Start date

Oct 15, 2024

Status verified date

Nov, 2024

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Aug 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

750 participants

Anticipated

Interventions and Outcome Measures

Arms

Study Cohort

Participants will receive up to 14 days of continuous cardiac monitoring

Interventions

Cardiac monitoring device

Portable, up to 14 days of monitoring

Primary outcome measure

  • Incidence of clinically important post-operative atrial fibrillation/atrial flutter [ Time Frame: Within 35 days of non-cardiac surgery ]

Central Contacts and Locations

Central contacts

Locations

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contacts

Research Coordinator

905-521-2100gregus@hhsc.ca

Juravinski Hospital

Recruiting

Hamilton, Ontario, Canada, L8V 1C3

More Information

Sponsor

Population Health Research Institute

Last update posted

Nov 7, 2024

Last verified

Nov, 2024

Keywords

  • Cardiac monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Population Health Research Institute on 2024-11-07.