RecruitingNCT06519747
DETECTion of PeriOperative Atrial Fibrillation After Noncardiac Surgery
Enhanced DETECTion of PeriOperative Atrial Fibrillation After Noncardiac Surgery with Continuous Electrocardiographic Monitoring
Sponsor
Population Health Research Institute
Enrollment
750 participants
Start Date
Oct 15, 2024
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 120 Years
Inclusion Criteria8
- 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.
Exclusion Criteria15
- 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;
- 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.
Interventions
DEVICECardiac monitoring device
Portable, up to 14 days of monitoring
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT06519747
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