Electromagnetic Interference by Transcutaneous Neuromuscular Electrical Stimulation in Patients With Optimizer(R) - a Pilot Safety Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 6
- 主要终点
- The patients with CCM-system are assessed for EMI during TENS-application
研究概览
简要总结
Systemic skeletal muscle atrophy (cachexia) is a typical side effect of chronic heart failure.
Patients with cachexia can benefit from transcutaneous electrical neuromuscular stimulation (TENS). It is applied to strengthen the musculature and improve exercise tolerance and quality of life.
It is unclear if application of TENS can cause electromagnetic interference (EMI) in patients with Optimizer® pacemaker systems for improvement of heart failure.
This pilot safety study enrolled 6 patients with chronic heart failure and reduced left ventricular ejection fraction. All patients had an Optimizer® pacemaker system implanted for a minimum of 6 months, no patients had any ventricular arrhythmic episode 3 months prior to the study, and all were in clinically stable condition and willing to participate in this study.
Neuromuscular stimulation was administered via TENS in 4 different modes (HF, LF, Burst, MF) on the right and left musculus trapezius and on both musculi quadriceps femoris. All patients were tested for EMI without or with cardiac contractility modulation (CCM) delivery of the Optimizer®-system respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •>18 years, with implantation of the Optimizer ® >6 months ago, clinically stable condition and without any ventricular arrhythmic episode in the last 3 months.
排除标准
- •Local swelling or edema at the site of stimulation, intolerance to electrical stimulation, or presence of other metallic implants at the site of stimulation
结局指标
主要结局
The patients with CCM-system are assessed for EMI during TENS-application
时间窗: 6 months
Electromagnetic interference can cause artificial sensing in pacemaker or ICD system. These artefacts may have the effect of suppressing the pacemaker pulses sensing of tachycardia in ICD. The patients will be exposed to electrical stimulations, which will be of different forces on the neck and the upper thigh with r4x. These impulses and the effects will be noted down. It will be investigated if there is an interference with the optimizer ® depending on the different sites of the electrical stimulations and the different impulse forces. Many patients with an Optimizer ® have simultaneously a pacemaker - or ICD implant. A special extra monitor will note if there are probable interferences with these pacemaker- or ICD implants.
次要结局
未报告次要终点
研究者
Michael Wolzt, Prof. MD
Prof Dr Michael Wolzt
Medical University of Vienna