NCT00964938已完成4 期
Multisite Pacing With a Quadripolar Left Heart Lead in Cardiovascular Resynchronization Therapy (CRT) Patients
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- dP/dt max
研究概览
简要总结
The purpose of this study is to evaluate the effects of multisite left ventricular (LV) biventricular (BiV) pacing on LV hemodynamics in CRT patients. It is hypothesized that the effect of simultaneous BiV pacing utilizing multisite LV pacing on LV hemodynamics will be superior to conventional BiV pacing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Have a scheduled CRT implantation at the participating clinical study site
- •Have NYHA functional class III or IV, ejection fraction less than or equal to 35%, and QRS duration greater than 120ms
- •Be undergoing a new St. Jude Medical CRT-D device system (including LV lead) implantation
- •Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed perioperative evaluations
排除标准
- •Have persistent or permanent atrial fibrillation
- •Have an intrinsic heart rate of <50 beats per minute
- •Have a recent myocardial infarction within 40 days prior to enrollment
- •Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures
- •Have had a recent CVA or TIA within 3 months prior to enrollment
- •Have had intravenous inotropic support in the last 30 days
- •Have ischemic etiology and are unable to tolerate stress echocardiography
结局指标
主要结局
dP/dt max
时间窗: acute: during implant procedure; 1 day
次要结局
未报告次要终点
研究者
研究点 (1)
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