An observational study in Atrial Fibrillation and Atrial Flutter, sponsored by Population Health Research Institute. Recruiting at 6 sites in Canada. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2024-11-07.
Sponsored by Population Health Research Institute · Observational
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.
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.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 750 is above the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Population Health Research Institute is the lead sponsor of 115 studies on the registry; 26 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adults who have undergone noncardiac surgery
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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;
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive up to 14 days of continuous cardiac monitoring
Device: Cardiac monitoring device
Portable, up to 14 days of monitoring
Incidence of clinically important post-operative atrial fibrillation/atrial flutter
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.
Time frame: Within 35 days of non-cardiac surgery
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
A multivariate logistic regression analysis of age, sex, surgical urgency, type of surgery, vascular disease, chronic kidney disease, and heart failure.
Time frame: Within 35 days of non-cardiac surgery
Plan to share: No
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