Transcutaneous Electrical Vagus Nerve Stimulation for Suppression of Ventricular Arrhythmias
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- VT burden
研究概览
简要总结
Ventricular arrhythmias are abnormal heart rhythms that arise from the bottom chambers of the heart. They can cause debilitating symptoms when they occur intermittently (these are called premature ventricular ectopics or PVCs) and can be life-threatening when they occur continuously (called ventricular tachycardia or VT). These are the most common causes of sudden cardiac death, especially in patients with pre-existing heart disease.
They can be a result of overactivation of the sympathetic nervous system, and in extreme circumstances, surgery to cut the nerve may be needed. A novel approach to target this nervous system using a transcutaneous electrical nerve stimulator (TENS) machine has successfully treated arrhythmias that come from the top chambers of the heart (atrial fibrillation). An ear clip is applied for an hour per day connected to a device (smaller than a phone) that can activate the parasympathetic nervous system (that counteracts the sympathetic nervous system). This is called Low-Level Tragus Stimulation (LLTS). Because it has been used for epilepsy for decades, we have evidence of a very high safety profile and tolerability. We plan to enrol 72 patients, 34 with many PVCs and 38 with VT, and randomise them to either first receive LLTS or first receive sham treatment (this will appear the same to the patient and researchers but without any meaningful vibrations being emitted in the sham group). Each patient will then swap over to the other treatment. We will compare whether the LLTS reduces the amount of ventricular arrhythmias during compared to the amount during the sham treatment period. We will use Holter monitors to measure the amount of PVCs after each period in the PVC group. VT patients have an implantable defibrillator that continuously monitors for VT episodes in this group. We will only enrol adults who can give informed consent, and study participation will not interfere with a patient's clinical treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Age > 18 years old.
- •Participants must understand and be willing to sign a written informed consent document.
- •PVC burden of >10% in a 24-hour period on Holter monitoring.
排除标准
- •Coronary artery disease
- •Known cardiac disease (heart failure or cardiomyopathy) in the documented absence of PVCs. Individuals with suspected PVC-induced cardiomyopathy heart failure, defined as cardiomyopathy or heart failure only diagnosed in the setting of a >10% PVC burden, will be allowed to participate.
- •A known diagnosis of Epilepsy.
- •Ongoing pregnancy or intention to become pregnant in the forthcoming 12 months.
- •Participants using a TENS device for any indication
- •Inclusion Criteria:
- •Participants with structural heart disease and a transvenous implantable cardioverter defibrillator (ICD) in situ
- •At least three clinically significant VT events (VT events defined as either >30 seconds of sustained VT, appropriate ICD ATP therapies or appropriate ICD shocks) in the six months before enrolment
- •Exclusion Criteria:
- •Heart failure syndrome with inotrope dependency or requiring mechanical assistance.
- •Reversible cause of arrhythmia (e.g. culprit electrolyte abnormality or toxin)
- •NYHA (New York Heart Association) stage IV heart failure
- •Myocardial infarction or cardiac surgery in the last six months
- •Life expectancy <12 months
- •Ongoing pregnancy or intention to become pregnant in the forthcoming 12 months.
- •Participants using a TENS device for any indication
结局指标
主要结局
VT burden
时间窗: Six months
Change in per-subject VT burden as adjudicated by continuous ICD monitoring during the active period versus the sham period (VT burden = the number of ATP events, ICD shocks and sustained (\>30 seconds) VT episodes) in the VT cohort
PVC Burden
时间窗: 14 days
Change in per-subject PVC burden compared to baseline during the active period versus sham period on 14-day Holter monitoring at the end of the period in the PVC cohort
次要结局
- 50% reduction in VT burden(Six months)
- Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) Score in the Active Phase versus Sham Control Phase (VT Cohort)(Six months)
- Change in 36-Item Short Form Survey (SF-36) Score in the Active Phase versus Sham Control Phase (PVC Cohort)(28 days)