Registry of Sleep Apnea Monitoring and Atrial Fibrillation in Pacemaker Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,257
- 试验地点
- 1
- 主要终点
- Evaluate at 12 Months follow-up the association between Atrial Fibrillation (AF) and Sleep Apnea (SA) severity based on data measured and stored in the pacemaker.
研究概览
简要总结
The purpose of the study is to evaluate at 12 Months follow-up the association between Atrial Fibrillation (AF) and Sleep Apnea (SA) severity based on data measured and stored in REPLY 200 DR pacemaker.
详细描述
The object of the investigation relates to the function named Sleep Apnea Monitoring or SAM function. This function is part of the REPLY 200 DR pacemakers, whose intended use is cardiac pacing. Sleep Apnea Syndrom (SAS) causes serious social and economic problems, not only because of its high prevalence but also because it is associated with increased cardiovascular morbidity and mortality.
Patients with Sleep Apnea often have arterial and pulmonary hypertension, a high risk of coronary artery disease, and heart failure, whereas a high percentage of patients show heart rhythm disturbances. In addition, these patients are at increased risk of being involved in traffic accidents, as well as suffering a decline in their family, social, and professional lives. Therefore, the prompt diagnosis of these patients could be of great importance. Today the gold standard for the diagnosis of SAS is overnight polysomnography (PSG) in a sleep laboratory. However, the shortage of sleep laboratories and the high cost of PSG render this method inadequate for widespread screening. For these reasons, in recent years, there have been attempts to develop alternative diagnostic with a view to simplify the diagnosis.
Thanks to the feature SAM included in the pacemaker, sequences of respiratory cycles are analyzed to detect, to count and to report abnormal breathing events during the night. This analysis is based on the Minute Ventilation (MV) signal. The MV signal represents the real time expansion/contraction of the thorax of the patient. It is derived of the transthoracic impedance periodic measurements. The device is able to provide the physician with day-by-day Respiratory Disturbance Index (RDI) equal to the sum of events divided by the number of hours per night. Physician will also access to the total number of events over the previous night presented per hour.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient eligible for implantation of a dual-chamber pacemaker according to current available guidelines
- •Patient with REPLY 200 DR implantation performed
- •Patient who provides signed and dated informed consent (according to the laws and regulations of the country in which the observational study is conducted)
排除标准
- •Inability to understand the purpose of the study or refusal to co-operate
- •Unavailability for routine follow-ups at the implanting centre
- •Already included in another clinical study that could affect the results of this study
- •Inability or refusal to provide informed consent
- •Patient is minor (less than 18-years old)
- •Patient is pregnant
- •Patient is forfeiture of freedom or under guardianship
结局指标
主要结局
Evaluate at 12 Months follow-up the association between Atrial Fibrillation (AF) and Sleep Apnea (SA) severity based on data measured and stored in the pacemaker.
时间窗: 12 months
The primary endpoint is to prove that the difference in AF occurrence between severe SA patients versus non severe is greater or equal to 6 % after 12 Months follow-up. AF will be measured using the Fallback Mode Switch duration (FMS) and SA using the Respiratory Disturbance Index (RDI), both stored in the device.
Collect all major serious adverse events as reported by the investigator during the duration of the study corresponding to death, myocardial infarction, stroke and re- intervention.
时间窗: 18 months
The co-primary endpoint is to evaluate the rate of composite endpoint of all major serious adverse events as reported by the investigator over 18 months follow up corresponding to death, myocardial infarction, stroke and re-intervention (at least one of the 4 types of major SAE per patient). These major SAE will be also assessed by type.
次要结局
- Assess prevalence of SA in pacemaker population based on RDI measured and stored in the pacemaker at 1, 6, 12 and 18 Months.(1, 6, 12 and 18 months)
- Occurrence of patients being treated for SA during the study(1, 6, 12 and 18 months)
- Evaluate at 1, 6, 12 and 18 Months follow-up the association between subclinical atrial fibrillation and sleep apnea based on data measured and stored in the pacemaker.(1, 6, 12 and 18 months)
- Evaluate at 1, 6, 12 and 18 Months follow-up the association between AF and SA severity based on data measured and stored in the pacemaker (quantitative data).(1, 6, 12 and 18 months)
- Occurrence of patients referred to sleep specialists - Occurrence of patients referred to sleep specialists. - Occurrence of patients having sleep exam during the study. - Occurrence patients being treated for SA during the study.(1, 6, 12 and 18 months)
- Occurrence of patients having sleep exam during the study(1, 6, 12 and 18 months)
- Evaluate at given time points any correlation between data stored in the device and clinical assessment related to the primary and secondary endpoints.(1, 6, 12 and 18 months)
- Evaluate at 1, 6, 12 and 18 Months follow-up the association between AF diagnosed on clinical assessment (ECG, holter, AF related serious adverse events: cardioversion, ablation…) and SA severity.(1, 6, 12 and 18 months)
- Evaluate at 1, 6 and 18 Months follow-up the association between AF and SA severity based on data measured and stored in the pacemaker (qualitative data).(1, 6 and 18 months)
- Compare RDI before and after SA treatment(1, 6, 12 and 18 months)
- Compare AF (using FMS duration and AF related hospitalization) before and after SA treatment when the patient is treated(1, 6, 12 and 18 months)
- Stability of the RDI.(1, 6, 12 and 18 months)
- Compare the sleep lab results with the RDI stored in the pacemaker(1, 6, 12 and 18 months)
- Association between SA severity and indication for pacemaker's implantation.(18 months)
- Collect serious adverse events throughout the study.(1, 6, 12 and 18 months)