Evaluation of the Ongoing Safety and Preliminary Efficacy of the Tetanizing Burst Therapy (TBT) System in Subjects Undergoing ICD Replacement Due to End-of-battery Life
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Less pain after TBT impulse with ICD shock compared to ICD shock alone
研究概览
简要总结
This study evaluates whether the addition of tetanizing burst therapy reduces the pain associated with ICD shocks
详细描述
The implantable cardioverter defibrillator is a device designed to rescue patients from life-threatening arrhythmias by delivering a defibrillation shock to allow restoration of cardiac rhythm. These defibrillation shocks are extremely painful, owing to sudden rapid contraction of thoracic and abdominal skeletal muscle, which, in addition to the heart, are stimulated by the defibrillation shock. Tetanizing Burst Therapy is a novel electrical waveform which tetanizes skeletal muscle with a brief burst of stimulation prior to the ICD shock, thereby reducing muscular contraction due to the shock. This study is designed for those patients who are already undergoing ICD replacement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or Female age 18-80 years, inclusive
- •Ability to understand and provide written informed consent
- •Normal sinus rhythm
- •Standard transvenous left-sided ICD referred for device replacement due to end of battery life
排除标准
- •Heart rate <40 or >90 bpm
- •Atrial fibrillation or pacemaker dependent
- •NYHA Class III/IV symptoms of HF
- •MI within 90 days of enrollment
- •Severe cardiac ischemia manifested by chest pain at rest or with minimal exercise
- •History stroke or TIAs
- •History of prior ICD pocket infection
- •ICD lead resistance that is too high or too low in the opinion of the investigator
- •Female who is pregnant or breastfeeding
- •Prior heart transplant
- •Serum electrolytes out of normal range at participating institution
结局指标
主要结局
Less pain after TBT impulse with ICD shock compared to ICD shock alone
时间窗: 5 minutes
Each subject will receive 2 therapies in random order delivered 5 minutes apart: * Tetanizing Burst Therapy + shock; and * Pure shock alone. Using the Numeric Pain Rating Scale (NRS) after each shock, the subject will be asked to provide a verbal score between 1 and 10, where 1 is no pain and 10 is the worst pain imaginable.
次要结局
- The device performance of tetanizing burst therapy in subjects undergoing ICD replacement as assessed degree of muscle contraction (Rate of Force Development)(5 minutes)
- The safety of tetanizing burst therapy in subjects undergoing ICD replacement as assessed by adverse events(7 days)
- The efficacy of tetanizing burst therapy in subjects undergoing ICD replacement as assessed by NRS verbal score(5 minutes)