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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:
additional risk factors include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rhythm monitoring group | Experimental | Patients randomized to the rhythm monitoring arm will assess their heart rhythm with a photoplethismography (PPG) based smartphone application (FibriCheckâ„¢). Measurements are performed three times daily and while experiencing symptoms. The patients start measuring immediately after discharge and continues until the scheduled postoperative consultation with the cardiologist or cardiac surgeon at 21-91days after discharge. |
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| Usual care | No Intervention | Patients randomized to the rhythm monitoring arm will be discharged without protocol mandated rhythm monitoring. A postoperative consultation is scheduled with the cardiologist or cardiac surgeon at 21-91days after discharge. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photoplethysmography based smartphone application for heart rhythm analysis (FibriCheckâ„¢) | Diagnostic Test | Heart Rhythm assessment using the FibriCheckâ„¢ application with the patient's proprietary smartphone, three times daily, from discharge until follow-up consultation (day 21-91 after discharge). |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with any of the following therapeutic interventions (composite 4-point endpoint) | Any of the following therapeutic interventions:
| 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. | 91 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to primary endpoint (primary outcome 1) | 91 days | |
| Proportion of participants with initiation or unplanned continuation of anticoagulation drug therapy resulting from arrhythmia detection | 91 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven | Leuven | 3000 | Belgium |
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|
| Post-operative atrial fibrillation (POAF) detection rate | 91 days |
| Time to POAF detection | 91 days |
| POAF detection rate in subjects with an indication for anticoagulation | 91 days |
| Detection rate of POAF lasting more than 6 hours | 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. | 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) | 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) | Two years |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D011183 | Postoperative Complications |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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