NCT05872776招募中不适用
A Multi Center Randomized, Double Blinded, Sham Controlled, Clinical Study Aimed to Determine the Efficacy of CardiaCare™ RR2 Home-care Neuromodulation System in Reducing Atrial Fibrillation Burden and Symptoms in Paroxysmal AF Patients
Ziv HealthCare Ltd.3 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年2月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Change in AF burden
研究概览
简要总结
Paroxysmal AF subjects with a documented ECG event of AF will be recruited to the study To assess the efficacy of CardiaCare™ RR2 wearable home-care neuromodulation system in reducing AF burden and symptoms in Paroxysmal AF patients
详细描述
After screening for 14 days with a continuous ECG monitoring device, eligible patients will be randomized to either active treatment or a sham treatment groups. For a treatment period of 12 weeks, patients will be prompted to self-conduct neuromodulation sessions based on: a. predetermined treatment regimen plus b. a detection algorithm. In addition, participants will measure at home, daily 2 min ECG's with the RR2 system two times a day and when feeling symptoms suspected as AF/AT/SVT or PAC's.
After 10 weeks of treatment patients will be requested to wear an ECG patch continuously for an additional period of 14 days.
Overall patients will participate in the study for 14 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women ages 18-85 years with history of documented paroxysmal (<7 days) atrial fibrillation
- •AF Burden (% time in AF) of more than 0.5% and less than 25% as evident by a continuous 14 days ECG recording at baseline (at minimum 168 hours)
- •Ability and willingness to sign an informed consent form
- •Ability and willingness to use CardiaCare home care device and ECG chest patch and has an available smart phone
- •Known symptomatic AF event over the recent 3 months
- •Willing not to change the antiarrhythmic treatment
排除标准
- •Hemodynamic instability (systolic blood pressure <100mmHg or heart rate>170 bpm at Baseline) during recruitment visit
- •Known history or current diagnosis of atrial flutter
- •An active myocardial infarction evident from ECG
- •Recent stroke or myocardial infarction (<6 months)
- •History of sick sinus syndrome 2nd or 3rd degree AV block, bifascicular block or prolonged (PR>300ms) 1st degree AV block
- •Unilateral or bilateral vagotomy
- •History of persistent AF with documented AF episodes of >7 days
- •Significant valvular disorder (i.e., prosthetic valve or hemodynamically relevant valvular diseases or valvular AF)
- •History of Impaired systolic function with EF<40 % or NY Class III or IV heart failure classification
- •Dilatated left atria with a diameter > 50mm as evident by an echocardiogram
- •Currently enrolled in another study
- •Recurrent vaso-vagal syncopal episodes
- •Pregnancy or breast feeding
- •Pacemaker or CRTD or any implanted electrical stimulating device
- •History of epilepsy or seizures
- •Peripheral neuropathy or dermatological condition affecting the tested upper extremity area
- •Unsuitable for participating in the study according to attending physician
结局指标
主要结局
Change in AF burden
时间窗: 14 weeks
Defined as % of time in AF, during screening period compared to end of treatment period.
次要结局
- Proportion of patients with 20% change in ATA /PAC (Premature Atrial Contractions, measured 14 days continuance ECG) burden(14 weeks)
- AF burden defined as the total number of AF events during screening period compared to end of treatment period.(14 weeks)
- Adherence: proportion of executed Vs. planned self-treatments delivered by each patient throughout the treatment period(14 weeks)
- Group change in acute reduction of PAC (number of PACs in 2 minute ECG) compared before and immediately after neuromodulation sessions(14 weeks)
- Mean group change in ATA (Atrial Tachyarrhythmias, score form 0 to 6)/ PAC ( Premature Atrial Contractions, number of PACs in 2 minute ECG ) burden from Screening period to End of treatment period(14 weeks)
- AF burden defined as the total number of symptomatic AF events during screening period compared to end of treatment period(14 weeks)
- Change from baseline compared to end of treatment period in Life quality & symptoms as assessed by AF AFEQT(from 0-poor to 100-great), EHRA Score (from I-no symptoms to IV-disabling symptoms) and SF36 questionnaires (form 0-worst to 100-best)(14 weeks)
- Number of AF episodes lasting 6 hours or longer in the treatment arm compared to the sham control(14 weeks)
- Safety- number of AE(14 weeks)
- Mean group change in acute reduction of PAC (number of PACs in 2 minute ECG) compared before to up to 1 hour after each neuromodulation session(14 weeks)
- Patient satisfaction and preferences as assessed by patient centric (0-none to 10-worst) & usability questionnaires (1-strongly disagree to 5-strongly agree)(14 weeks)
研究者
研究点 (3)
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