A multicentre, prospective, randomized, double-blind, sham-controlled clinical study aimed to determine efficacy of CardiaCareâ„¢ RR2 (wearable home-care neuromodulation system) in reducing AF burden and symptoms in Paroxysmal AF patients.
试验速览
- 阶段
- 3 期
- 状态
- Other
- 入组人数
- 70
- 试验地点
- 13
- 主要终点
- Change from baseline in AF burden compared to end of treatment wherein AF burden is defined as percentage of time in AF (time in AF divided by total time monitored) during the 2 weeks’ measurement period in the active group compared to sham.
研究概览
简要总结
Available treatments of AF have limited effects: 50%ablation failure rates at 5 years, 80% cardioversion failure rates at 1 year,and limited efficacy and multiple drug side-effects. There is an unmet need foradjuvant therapy to standard care in a home-care setting. The rationale forthis study is to evaluate clinical outcomes and collect data of the CardiaCare™(the world’s first Non-Invasive Nerve Stimulation Digital Therapeutic forCardiovascular Care).
CardiaCare™ is the world’s first non-invasivenerve stimulation digital therapeutic for cardiovascular care and the firsthome-care therapy delivery and real time monitoring system for people with AF.CardiaCare™ is a wrist-band with medical grade ECG but with non-invasiveneuromodulation (nerve stimulation) capabilities that mediate a cardiovascularantiarrhythmic response that reduces atrial fibrillation burden.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Men and women of 18-85 years with mild to moderate (<7 days) paroxysmal atrial fibrillation.
- •AF burden (% of time in AF) of more than 0.5% and less than 25% as evident by a continuous 14 days ECG recording at baseline
- •Paroxysmal AF subjects with a documented ECG event of AF (<7 days from onset) will be recruited into the study from hospital out-patient settings or patient database.
- •Willing and capable of providing informed consent.
- •Known symptomatic AF event over the recent 2 months.
- •Symptomatic AF despite stable dose of anti-arrhythmic drugs (at least 2 months)
- •Willing not to change the antiarrhythmic treatment.
- •Consent for using effective methods of contraception during the entire study period.
- •Subjects able to comprehend and comply with study requirements and procedures.
排除标准
- •Patients will be excluded if they have any of the following:
- •Hemodynamic instability (systolic blood pressure <100mmHg or heart rate>170 bpm at Baseline) during recruitment visit
- •Left ventricular dysfunction (Left ventricular ejection fraction <40%) and Left atrial dilatation (>50mm)
- •Significant valvular disorder (i.e., prosthetic valve or hemodynamically relevant valvular diseases)
- •Recent stroke or myocardial infarction (<6 months)
- •Severe heart failure (NYHA III or IV)
- •Known history or current diagnosis of atrial flutter.
- •An active myocardial infarction evident from ECG
- •Recurrent Vaso-vagal syncopal episodes
- •Unilateral or bilateral vagotomy
- •Sick sinus syndrome, 1st, 2nd or 3rd degree AV block, bifascicular block or prolonged (PR>300ms)
- •Pregnancy or breastfeeding
- •Peripheral neuropathy or dermatological condition of upper extremity
- •Pacemaker or CRTD or any implanted electrical stimulating device
- •History of epilepsy or seizure
- •Unsuitable for participation in the study as per Investigator’s discretion.
结局指标
主要结局
Change from baseline in AF burden compared to end of treatment wherein AF burden is defined as percentage of time in AF (time in AF divided by total time monitored) during the 2 weeks’ measurement period in the active group compared to sham.
时间窗: Baseline, End of treatment (26 weeks)
次要结局
- The total number of AF events(The total number of symptomatic AF events)