Biventricular Pacing and Stimulation of the Diaphragm in Patients With Severe Heart Failure Following Heart Surgery (Epiphrenic II Pilot Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Left ventricular ejection fraction
研究概览
简要总结
This study examines whether a permanent stimulation of the diaphragm improves left ventricular function in patients with severe heart failure following heart surgery.
详细描述
Previous studies have shown that temporary stimulation of the diaphragm using an electrode to the phrenic nerve reduces electrical mechanical activation time (EMAT) and improves left ventricular function. This study examines whether patients with severe heart failure, who require permanent biventricular pacing after heart surgery, may benefit from an additional permanent electrode that stimulates the diaphragm. Heart function is assessed by echocardiography and acoustic cardiography (Audicor, Inovise Medical Inc., Portland, USA).
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
- None
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
- •Patients following open heart surgery who need permanent pacing
排除标准
- •Patients with fast changing need of vasopressors
研究组 & 干预措施
Stimulation of diaphragm
干预措施: Stimulation of the diaphragm (Device)
结局指标
主要结局
Left ventricular ejection fraction
时间窗: One day
次要结局
- Brain natriuretic peptide (BNP)(One day)
- 6-minutes walking distance(One day)
- NYHA functional class(One day)
研究者
Prof. Paul Erne
Prof. Paul Erne
Luzerner Kantonsspital