Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes (NoVa-PVC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- PVC Burden
研究概览
简要总结
A prospective sham-controlled randomized clinical trial to assess the effect of low-level tragus stimulation (LLTS) in patients with frequent premature ventricular complexes (PVCs)
详细描述
This is a two-center, prospective, cross-over, sham-controlled, double-blinded, randomized clinical trial. All the patients will receive a cardiac event monitor at baseline for 28 days, the patient will switch the ePatch after 14 days . Patients will be allocated to either LLTS first and then sham-stimulation, or sham-stimulation first and then LLTS. Each treatment period (sham-stimulation and LLTS) will last 10 days. The Parasym device will be used, and the patients will receive LLTS or sham-stimulation for 1 hour daily. The wash-out period between the two treatments will last 8 days. Patients will be continually monitored via event monitor for 28 days in duration.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (>18 years old) but < 80 years of age
- •Symptomatic PVCs or asymptomatic PVCs with a burden > 5%
- •Intolerant to or unwilling to take beta blockers and nondihydropyridine calcium channel blockers or beta blockers and nondihydropyridine calcium channel blockers have proved ineffective
排除标准
- •Ischemic cardiomyopathy with LVEF < 40%
- •Severe heart failure (New York Heart Association Class III, or IV) or valve disease
- •Sustained ventricular tachycardia
- •Structural heart disease or myocardial scar
- •Pregnancy or nursing
- •Patients with known thyroid issues, on renal dialysis.
- •Patients with prolonged first-degree block, high degree AV block (2nd or 3rd degree), bivascular block and documented sick sinus syndrome
- •Hypotension due to autonomic dysfunction
- •Patients with cardiac implantable electronic device (ICD or PPM) , hearing aid implants or any implanted metallic or electronic device
- •Patients who have had prior cervical vagotomy
- •Patients with skin on the tragus that is broken or cracked
- •Patients with a history of baseline cardiac disease or atherosclerotic cardiovascular disease, including congestive heart failure (CHF), known severe coronary artery disease or recent myocardial infarction (within 5 years) and patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
结局指标
主要结局
PVC Burden
时间窗: 28 days
Daily PVC Count by event monitor
次要结局
- Quality of life survey(28 days)
- Heart Rate Variability(28 days)
- PVC Morphology(28 days)
研究者
Stavros E Mountantonakis
Director, Cardiac Electrophysiology, Lenox Hill Hospital
Northwell Health