CTRI/2013/11/004148招募中不适用
Extension 5 Hz Study of Neural Regulation Therapy on Myocardial Function in Heart Failure (Extension ENCORE 5 Hz).
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- The primary safety objective will be the incidence of device-related complications.
研究概览
简要总结
A followup safety study to see the long-term effect of safety and efficacy of Cyberonics VNS Therapy System for the treatment of symptomatic heart failure for an additional 6 months.
RefCTRI Number for the main study is CTRI/2012/05/002681
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients enrolled in the study must meet all of the following criteria:
- •Willing and capable of providing informed consent
- •Completed the ENCORE Extension study (18-month study).
排除标准
- •Patients who meet any of the following criteria are not eligible to be enrolled in the study:
- •Patients with a life expectancy of less than 12 months per physician judgement.
- •Women of childbearing potential who are or might be pregnant at the time of the study or breastfeeding
- •Patients scheduled for Cardiac Resynchronization Therapy (CRT) in the next 6 months.
结局指标
主要结局
The primary safety objective will be the incidence of device-related complications.
时间窗: Baseline, 6 and 12 months
The primary efficacy objective is to evaluate the change in measures of cardiac function (LVESV and EF)
时间窗: Baseline, 6 and 12 months
次要结局
- 6-minute walk(Baseline, 6 and 12 months)
- Left Ventricular End Systolic Diameter (LVESD)(Baseline, 6 and 12 months)
- NYHA Class(Baseline, 6 and 12 months)
- Heart rate variability (HRV)(Baseline, 6 and 12 months)
- Blood biomarkers (brain natriuretic peptide,(NT-proBNP, creatinine)
- Quality of Life based on patient questionnaire(Baseline, 6 and 12 months)
研究者
研究点 (5)
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