Using Electrical Nerve Stimulation to Control Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Change in AF Burden
研究概览
简要总结
The purpose of this study is to examine if sending mild electrical signals just under your skin will improve atrial fibrillation symptoms by controlling your heart rate.
详细描述
Patients will have a 1:1 randomization to receive subcutaneous electrical nerve stimulation (ScNS) to observe if the stimulation can reduce atrial fibrillation burden in patients with symptomatic atrial fibrillation (AF). All subjects will undergo the implant of a neurostimulator lead. The experimental group will receive stimulation and the control group will not receive stimulation. All subjects will complete the same follow up visits to compare the 2 groups.
Primary Objective: To test the hypothesis that chronic subcutaneous nerve stimulation can reduce AF burden in patients with severe symptomatic AF unresponsive to conventional therapies
The secondary objective:
To test the hypotheses that the effect of ScNS on the following endpoints is different between the two randomization groups:
- Time-dependent reduction of AF burden
- Effects of ScNS on ventricular rate control during AF
- Reduction of SKNA
- Improvement of quality of life
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
- Single (Participant)
盲法说明
Subjects will not be aware whether the ScNS is turned on or off. However, after three weeks from the initial surgery, control subjects that decide to the second procedure will be aware of what group they were randomized to.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 75 years of age
- •Symptomatic Paroxysmal AF.
- •Symptomatic paroxysmal AF is defined by AF with patient-reported perception of one or more of the following symptoms: palpitations, dizziness/presyncope, syncope, dyspnea, chest pain, malaise, and fatigue and activity intolerance.
- •There is at least one ECG-documented AF episode.
- •Unresponsive to conventional therapy is defined by not responding to at least 1 antiarrhythmic drug (class I, class III, or atrioventricular nodal blocker).
- •The left atrial size <50 mm by transthoracic echocardiography documented by eligibility visit echocardiogram
- •Documented atrial fibrillation as defined as atrial fibrillation >30 seconds in duration with an atrial fibrillation burden determined by a minimum of 7 days of continuous ePatch monitoring within 6 months before surgery.
排除标准
- •Patients without AF episodes during monitoring period will be excluded from the study and count as screen failure
- •Left ventricular ejection fraction <40%
- •Heart failure with functional classes III or IV
- •Recurrent vasovagal syncope
- •Valvular AF (severe mitral regurgitation, mitral stenosis)
- •Congenital heart diseases
- •Wolff Parkinson-White Syndrome
- •Stroke within the past 6 months
- •Any history of myocardial infarction
- •Malignancies with a life expectancy of < 1 year
- •A history of ablation procedures to treat left atrial tachyarrhythmias or other serious comorbidity
- •Any history of sustained ventricular tachycardia (VT) defined by (1) > 30 s in duration or (2) < 30 s in duration, but is associated with hemodynamic consequences such as hypotension and syncope.
- •Patients with a vagal nerve stimulator
- •Active thyrotoxicosis
- •Sick sinus syndrome with symptomatic bradycardia
- •Heart rate < 50 beats per minute in sinus rhythm on 12-lead ECG
- •Systolic blood pressure < 90 mm Hg
- •Any experimental medication concomitantly or within 4 weeks of participation in the study
- •Subjects with cardiac implantable electronic device (CIED) such as pacemakers and implantable cardioverter-defibrillators (ICDs)
- •Pre-existing neuromodulation devices, such as vagal nerve stimulators, spinal cord stimulators and sacral nerve stimulators
- •People with a history of allergy to ECG electrodes, adhesive tape, or nylon
- •Pregnant women
结局指标
主要结局
Change in AF Burden
时间窗: 2 weeks
Using mobile cardiac telemetry (MCT) to observe if AF burden is lower at 2 Weeks compared to Baseline in the active treatment group than the sham control group
次要结局
- Ventricular Rate Control(3 Months)
- Average Skin Sympathetic Nerve Activity (SKNA)(3 months)
- Quality of Life - EQ-5D-5L(3 months)
- Quality of Life - AFEQT(3 months)
研究者
Peng-Sheng Chen
Staff Physician
Cedars-Sinai Medical Center