A Prospective Clinical Study Aimed to Assess the Technical Feasibility of RR2 Wearable Home Care Neuromodulation System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Assessment of system ECG function by the Number of ECG checks successfully conducted with record sent, received and stored by the system.
研究概览
简要总结
RR2 is a medical, home-care, digital therapeutic, wearable device. Its main purpose is to deliver prescheduled, non-invasive, peripheral neuromodulation therapy, in conjunction with standard medical care, to relieve AF symptoms, recurrence and overall burden.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Men and women aged ≥18 with ECG documented and symptomatic recent onset atrial fibrillation (AF), lasting less than 48 hours
- •Symptoms related to AF with high probability
- •Recent conversion or cardioversion to normal sinus rhythm (NSR) as evident by a documented electrocardiograms (ECG)
- •Participants are able and willing to provide a signed informed consent
- •Participants are able and willing to use RR2 homecare device and wear an ECG patch or a Holter monitor for 24 hours.
排除标准
- •Hemodynamic instability (systolic blood pressure <100mmHg or heart rate >170 bmp)
- •An active myocardial infarction evident from ECG signs
- •Presence of pre-excitation syndrome
- •History of sick sinus syndrome
- •History of persistent AF with documented episodes of >7 days
- •Heart failure, acute or chronic
- •Participants currently enrolled in another study
- •Recurrent vaso-vagal syncopal episodes
- •Pregnancy or breast feeding
- •Pacemaker or Cardiac resynchronization therapy defibrillator (CRT-D) or any implantable electrical stimulating device
- •History of epilepsy or seizures
- •Peripheral neuropathy affecting the tested upper extremity
- •Participants unsuitable for participating in the study according to attending physician
- •Know allergy to .. (all materials that are in contact with patient's skin)
结局指标
主要结局
Assessment of system ECG function by the Number of ECG checks successfully conducted with record sent, received and stored by the system.
时间窗: 8 weeks
Number of ECG checks successfully conducted with record sent, received and stored by the system.
Assessment of system Nerumodulation function by the Number of self-treatments successfully conducted with record sent, received and stored by the system.
时间窗: 8 weeks
Number of self-treatments successfully conducted with record sent, received and stored by the system.
次要结局
- AFEQT quality of life questionnaire(8 weeks)
- Heart rate variability (HRV)(8 weeks)
- First AF event(8 weeks)
- Number of patients with acute reduction of PAC's 90 min(8 weeks)
- Frequency of self-treatments during the treatment period(8 weeks)
- Number of analyzed ECG(8 weeks)
- AF recurrence(8 weeks)
- Centric questionnaire(8 weeks)
- Unscheduled emergency department visits(8 weeks)
- Number of patients with reduced premature atrial complexes (PAC's) and atrial runs(8 weeks)
- AF burden(8 weeks)