The objective of the study is to evaluate the clinical consequences following the detection of postoperative atrial fibrillation or flutter (POAF) using a remote heart rhythm monitoring strategy with a photoplethysmography based smartphone technology in the early postoperative period after discharge.
A predefined subgroup analysis of the outcomes described below will be performed in the following subgroups: * Subjects not on anticoagulation drug therapy (for a planned duration of \>45 days) at discharge. * Subjects with no history of AF prior to surgery and no POAF lasting \>24h in hospital. * Subjects with a CHADSVASC score ≥ 4 or a CHADSVASC score ≥ 2 with at least one additional risk factor associated with the risk of developing POAF. additional risk factors include: * chronic obstructive pulmonary disease * sleep apnea * impaired renal function * left atrial enlargement * elevated body mass index * combined CABG with valve repair or replacement
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
450
Heart Rhythm assessment using the FibriCheck™ application with the patient's proprietary smartphone, three times daily, from discharge until follow-up consultation (day 21-91 after discharge).
University Hospitals Leuven
Leuven, Belgium
Proportion of participants with any of the following therapeutic interventions (composite 4-point endpoint)
Any of the following therapeutic interventions: * Initiation or unplanned continuation of anticoagulation drug therapy resulting from arrhythmia detection * Initiation or increase in dose regimen of anti-arrhythmic drug therapy (Vaughan-williams class 1 or 3) * Cardioversion * Cardiac implantable electronic device (CIED) implantation
Time frame: 91 days
Time to detection of a postoperative adverse event
Prespecified postoperative adverse events: 1.1. Acute respiratory insufficiency 1.2. Pleural effusion 1.3. Pneumonia 1.4. Pulmonary Embolism 1.5. Pneumothorax 1.6. Atelectasis, leading to respiratory insufficiency 2.1. Acute myocardial infarction 2.2. Symptomatic arrhythmia 2.3. Pericardial effusion 2.4. Pericarditis 2.5. Endocarditis 2.6. Systemic embolism 2.7. Cardiogenic shock 3.1. Acute stoke including cerebrovascular accident (CVA) and transient ischemic attack (TIA) 4.1. Renal failure, defined as: \>50% increase in serum creatinine or initiation of renal replacement therapy 4.2. Urinary tract infection, requiring antibiotic treatment 5\. Wound related complications requiring surgical intervention or antibiotic treatment. 6\. Sepsis 7\. Other unplanned hospitalisations will be classified by the research team as 'postoperative adverse event' or 'unrelated to the cardiac surgery procedure'. Such events will be reported with the study results.
Time frame: 91 days
Time to primary endpoint (primary outcome 1)
Time frame: 91 days
Proportion of participants with initiation or unplanned continuation of anticoagulation drug therapy resulting from arrhythmia detection
Time frame: 91 days
Post-operative atrial fibrillation (POAF) detection rate
Time frame: 91 days
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Time to POAF detection
Time frame: 91 days
POAF detection rate in subjects with an indication for anticoagulation
Time frame: 91 days
Detection rate of POAF lasting more than 6 hours
Time frame: 91 days
The EQ-5D-5L questionnaire score evolution between inclusion and follow-up consultation
EQ-5D-5L is a EuroQol five-dimension scale questionnaire. The participant rates his or her own level of impairment across dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) from 1 to 5 and global health rating on a visual analogue scale (EQ-VAS) from 1 to 100.
Time frame: 91 days
Number of mayor adverse cardiac outcomes (All-cause death, Ischemic stroke, Myocardial infarction, Systemic embolism)
Hierarchical secondary outcomes (will be analysed if the primary outcome is positive)
Time frame: Two years
Number of mayor adverse cardiac outcomes (secondary outcome 9) with addition of cardiovascular hospitalisations
Hierarchical secondary outcomes (will be analysed if the primary outcome is positive)
Time frame: Two years