Detection of Atrial Fibrillation After Cardiac Surgery (NCT02793895) | Clinical Trial Compass
TerminatedNot Applicable
Detection of Atrial Fibrillation After Cardiac Surgery
Stopped: COVID-19 pandemic
Canada336 participantsStarted 2017-02-24
Plain-language summary
The aim of the SEARCH-AF trial is to evaluate a novel diagnostic tool for detecting post-operative atrial fibrillation or flutter (POAF/AFL) in cardiac surgical subjects during the early, sub-acute post-operative period. The population includes cardiac surgical subjects who have either developed or are at risk for developing new onset POAF/AFL and who are at risk for stroke, as determined by their CHA2DS2-VASC (congestive heart failure, hypertension, age ≥75 years (2 points), diabetes mellitus, previous stroke/transient ischemic attack (TIA) (2 points), vascular disease, age 65-74 years, sex class (female)) score. These subjects must not have had a history of AF/AFL before cardiac surgery.
The intervention group will undergo up to 30 days of continuous cardiac rhythm monitoring with an adhesive, patch-based monitor (Medtronic SEEQ™ mobile cardiac telemetry system or the CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device). The control group will receive usual care, which does not involve planned cardiac rhythm testing within the first 30 days after study randomization. The primary outcome is documentation of sustained atrial fibrillation or flutter within the first 30 days after randomization. In addition, subjects in both groups will undergo 14 days of continuous cardiac rhythm monitoring with the Medtronic SEEQ™ mobile cardiac telemetry system or the CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device at 6±1 months after their index cardiac surgery.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female age ≥18 years.
✓. Isolated CABG or valve replacement/repair +/- CABG performed at the index surgical procedure.
✓. At elevated risk of stroke and for having POAF/AFL, defined as having a CHA2DS2-VASC (congestive heart failure, hypertension, age ≥75 years (2 points), diabetes mellitus, previous stroke/transient ischemic attack (TIA) (2 points), vascular disease, age 65-74 years, sex class (female)) score of ≥4 or ≥2 with at least 1 of the following risk factors for developing POAF/AFL:
✓. Able to provide written informed consent.
Exclusion criteria
✕. Atrial fibrillation or flutter at the time of randomization.
✕. Known previous history of AF/AFL, diagnosed pre-operatively (note: documentation of a history of AF/AFL without accompanying rhythm proof will suffice).
✕. Documentation of continuous AF/AFL for ≥24 hours during the in-hospital stay for the index cardiac surgery.
✕. Subjects who, at the discretion of the treating cardiac surgery team, would be treated and discharged with oral anticoagulation due to POAF/AFL.
What they're measuring
1
Number of participants with a cumulative atrial fibrillation/flutter (AF/AFL) duration of ≥6 minutes or documentation of AF/AFL by a 12-lead electrocardiogram