Connected Cardiology to Control Cardiac Rythm
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 400
- 主要终点
- The total number of episodes AF that lasts 5 min or more recorded on long-term monitoring
研究概览
简要总结
New-onset of atrial fibrillation (AF) and atrial arrythmia (AA) in general, is important as it exposes patients to stroke or other embolic complications not to mention the risk of heart failure. AF detection in high risk populations such as patients with a recent stroke or TIA or, symptomatic patients with multiple risk factors for AF, is performed with long-term electrocardiography monitoring using frequently implantable loop recorders (ILR). These recorders have their own limitations related to the invasive nature of the device implanted under the skin of the chest with limited acceptation by the patients. Smart watches appear as useful alternatives, but they need to be evaluated in an all-comer population of patients highly exposed to AF, different from the large population studies conducted in healthy young adults with a low incidence of AF. The unique features of CardiacSense Medical System suggest that we could have an accurate noninvasive detection of AF in a selected population very much exposed to the risk of atrial fibrillation, the most frequent atrial arrhythmia.
详细描述
Study design :
This clinical investigation is a comparative, non-randomised, one group, controlled study.
Each patient represents its own control. The study will envolve 400 participants
Hypothesis :
Our hypothesis is that CardiacSense Medical System is an effective, safe, and better accepted alternative for detecting atrial fibrillation (AF) in a high-risk population than implantable loop recorders (ILRs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patient aged 18 years or more
- •Patient having signed free, informed, and written consent
- •Patient presenting one of the following situations :
- •Post-stroke or TIA patient with an already in place ILR
- •Patient with symptoms evocative of AF (e.g. increased heart rate, chest pain) with an already in place ILR
- •Post-PFO closure patient with an already in place ILR
- •Patient in sinus rhythm treated for the prevention of paroxysmal AF with an already in place ILR
- •Patient at high risk of AF (at the discretion of the investigator) with an already in place ILR
- •Patient with a period of risk of AF ≥ 3 months.
排除标准
- •Patient under legal protection
- •Pregnant and/or breastfeeding women
- •Patient with pacemakers, or ICD
- •Patient with blood flow deficiency-related conditions
- •Patient with tattoo or injured skin on the wrist
- •Patient with tremors or otherwise unable to remain still for 15 minutes
- •Patient without two hands and sufficient fingers to complete the study.
结局指标
主要结局
The total number of episodes AF that lasts 5 min or more recorded on long-term monitoring
时间窗: between 3 and 12 months according to the period at risk of AF
The total number of episodes AF that lasts 5 min or more recorded on long-term monitoring using the CardiacSense Medical Watch by pulse plethysmography (PPG) only vs the gold standard method of ILR ECG recording, over the same period of monitoring by the two devices for each patient.
次要结局
- Degree of invasiveness, comfort, and ease of use of both devices(between 3 and 12 months according to the period at risk of AF)
- Incidence and severity of CS device vs ILR devices(between 3 and 12 months according to the period at risk of AF)
- The total number of AA episodes that lasts 5 min or more recorded on long-term monitoring(between 3 and 12 months according to the period at risk of AF)
- The total number of episodes AF that lasts 5 min or more recorded on long-term monitoring(between 3 and 12 months according to the period at risk of AF)
- The total duration of AF episodes that lasts 5 min or more(between 3 and 12 months according to the period at risk of AF)
- Medico-economic evaluation according to the AP-HP hospital costs(between 3 and 12 months according to the period at risk of AF)