Randomized Study of Endovascular Versus Epicardial Lead Placement for Resynchronization Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- CHF Hospitalizations & mortality
研究概览
简要总结
The primary goal of this study is to evaluate the use of robotically -assisted device leads as a primary strategy for heart resynchronization.This trials aims to compare transvenous lead placement with robotic lead placement for cardiac resynchronization therapy.
详细描述
A secondary goal is to explore the link between efficacy of CRT and inotropic contractile reserve as measured by dobutamine stress echocardiography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic NYHA class III or IV heart failure from idiopathic or ischemic heart failure
- •QRS interval greater than or equal to 130 msec
- •Left ventricular end diastolic diameter greater than or equal to 55 mm
- •left ventricular ejection fraction less than or equal to 35
- •Willingness to participate
排除标准
- •Acute renal failure; active GI bleeding; unexplained fever which may be due to an infection
- •untreated active infection
- •acute stroke
- •severe uncontrolled systemic hypertension
- •severe systemic electrolyte imbalance
- •severe concomitant illness that drastically shortens life expectancy
- •severe coagulopathy
- •history of severe COPD and inability to tolerate single lung ventilation
- •History of prior left sided thoracotomy
- •history of recent intravenous drug use
- •concomitant psychiatric diagnosis that impairs patient's ability to comply with study protocol
- •participation in another investigational protocol
研究组 & 干预措施
Robotic placement of CS lead
CS leads placed epicardially in the area of increased dyssynchrony as demonstrated by low dose dobutamine stress testing.
干预措施: Primary epicardial placement of left ventricular lead (Procedure)
Transvenous placement of CS lead
CS lead will be placed transvenously
干预措施: Transvenous placement of left ventricular lead (Procedure)
结局指标
主要结局
CHF Hospitalizations & mortality
时间窗: one year post implant.
Heart failure and mortality will be assesd along with six minute hall walk tests
次要结局
未报告次要终点