Atrial FibrillationDETECT-POAFNCT06519747
DETECTion of PeriOperative Atrial Fibrillation After Noncardiac Surgery
An observational study of Atrial Fibrillation and Atrial Flutter, run by Population Health Research Institute at 6 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter
- What is being tested?
- Cardiac monitoring device
- Type of treatment
- Medical device
- How many people
- 750 participants
- Where
- 6 sitesCanada
- Study dates
- 15 Oct 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults who have undergone noncardiac surgery
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kate Brady contact
6 sites in 1 country
Canada6 sites, 6 recruiting
- Recruiting
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Research Coordinator, 905-521-2100 ext. 44156, gregus@hhsc.ca
Mohamed Panju, MD
- Not yet recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Vikas Tandon, MD
- Recruiting
Juravinski Hospital
Hamilton, Ontario, L8V 1C3
Ameen Patel, MD
- Not yet recruiting
London Health Sciences Centre - University Hospital
London, Ontario, N6A 5A5
Marko Mrkobrada, MD
- Not yet recruiting
Hôpital Fleurimont du Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5H3
Félix Ayala-Paredes, MD
- Not yet recruiting
Niagara Health System - St. Catharine's Site
St. Catharines, Ontario, L2S 0A9
Leonard Blair, MD
About this study
Official title: 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.
Read the 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
- Being tested
- Cardiac monitoring device
- Keywords
- Cardiac monitoring
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac monitoring deviceDevice
Portable, up to 14 days of monitoring
| Study group | Role | What they receive |
|---|---|---|
| Study Cohort | Participants will receive up to 14 days of continuous cardiac monitoring Receives: Device: Cardiac monitoring device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 35 days of non-cardiac surgery
Secondary outcomes (10)
Incidence of sustained ventricular arrhythmia
Measured: Within 35 days of non-cardiac surgery
Incidence of sinus node dysfunction
Measured: Within 35 days of non-cardiac surgery
Incidence of high-grade atrioventricular block
Measured: Within 35 days of non-cardiac surgery
Incidence of death
Measured: Within 35 days of non-cardiac surgery
Incidence of clinically important post-operative atrial fibrillation/atrial flutter
Measured: Within 14 days of continuous cardiac monitoring
Incidence of clinically important post-operative atrial fibrillation/atrial flutter detected by clinical monitoring only
Measured: Within 35 days of non-cardiac surgery
Incidence of clinically important post-operative atrial fibrillation/atrial flutter define with minimum duration of 6 minutes
Measured: Within 35 days of non-cardiac surgery
Incidence of clinically important post-operative atrial fibrillation/atrial flutter detected by study device monitoring only
Measured: Within 35 days of non-cardiac surgery
Proportion of participants meeting eligibility criteria for ASPIRE-AF study
Measured: 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.
Measured: Within 35 days of non-cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start15 Oct 2024
- Primary completion15 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Conen, MD, MPH, Principal investigator, Population Health Research InstituteMichael K Wang, MD, Principal investigator, Population Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519747
- Sponsor's protocol ID
- 2023-DETECTPOAF
- Acronym
- DETECT-POAF
- Status last verified
- Nov 2024
- First submitted
- 9 Jul 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced DETECTion of PeriOperative Atrial Fibrillation After Noncardiac Surgery with Continuous Electrocardiographic Monitoring
- ClinicalTrials.gov ID
- NCT06519747
- Acronym / sponsor ID
- DETECT-POAF / 2023-DETECTPOAF
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Keywords
- Cardiac monitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | Device: Cardiac monitoring deviceParticipants will receive up to 14 days of continuous cardiac monitoring |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who have undergone noncardiac surgery
Key inclusion criteria (8 listed)
- Had undergone noncardiac surgery within the past 72 hours and requiring, or expected to require, at least one of the following:
- Have one of the following high-risk criteria;
- Provide written informed consent to participate.
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac monitoring devicePortable, up to 14 days of monitoring | Device | Study Cohort |
Primary outcome
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: 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.
10 secondary outcomes
Incidence of sustained ventricular arrhythmia
Time frame: Within 35 days of non-cardiac surgery
Incidence of sinus node dysfunction
Time frame: Within 35 days of non-cardiac surgery
Incidence of high-grade atrioventricular block
Time frame: Within 35 days of non-cardiac surgery
Incidence of death
Time frame: Within 35 days of non-cardiac surgery
Incidence of clinically important post-operative atrial fibrillation/atrial flutter
Time frame: Within 14 days of continuous cardiac monitoring
Incidence of clinically important post-operative atrial fibrillation/atrial flutter detected by clinical monitoring only
Time frame: Within 35 days of non-cardiac surgery
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
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
Proportion of participants meeting eligibility criteria for ASPIRE-AF study
Time frame: Within 35 days of non-cardiac surgery
Multivariate odds ratio of risk factors associated with the occurrence of clinically important POAF
Time frame: Within 35 days of non-cardiac surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kate Brady contact
David Conen, MD, MPH principal investigator
Population Health Research Institute
Michael K Wang, MD principal investigator
Population Health Research Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Atrial Flutter, run by Population Health Research Institute at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vitheya Thanabalan (+1 905-296-2710, detectpoaf@phri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of clinically important post-operative atrial fibrillation/atrial flutter (time frame: Within 35 days of non-cardiac surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.