Remote Heart Rhythm Monitoring Using Photoplethysmography-based Smartphone Technology for the Early Detection of Atrial Fibrillation and Adverse Events After Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Time to detection of a postoperative adverse event
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject underwent any of (including a combination of) the following surgical procedures during index hospitalization. (coronary artery bypass graft, surgical repair or replacement of a cardiac valve)
- •Subject provides informed consent
- •Subject understands and agrees to comply with planned study procedures.
- •Subject is able to perform heart rhythm measurement using the FibriCheck application at home.
排除标准
- •Pacemaker dependent heart rhythm
- •Permanent AF/Aflutter or AF/Aflutter present at the time of inclusion
- •Insufficient cognitive or comprehensive level of Dutch to participate to the trial.
- •No smartphone available at home.
结局指标
主要结局
Time to detection of a postoperative adverse event
时间窗: 91 days
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.
Proportion of participants with any of the following therapeutic interventions (composite 4-point endpoint)
时间窗: 91 days
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
次要结局
- The EQ-5D-5L questionnaire score evolution between inclusion and follow-up consultation(91 days)
- Number of mayor adverse cardiac outcomes (All-cause death, Ischemic stroke, Myocardial infarction, Systemic embolism)(Two years)
- 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)
- 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)
- Number of mayor adverse cardiac outcomes (secondary outcome 9) with addition of cardiovascular hospitalisations(Two years)