Real Time 3-Dimensional Echocardiography for Left Ventricular Lead Site Selection to Reduce Cardiac Resynchronization Therapy Non-Responder Rates (ENVISION)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Responder Rate
研究概览
简要总结
The purpose of this study is to demonstrate that cardiac resynchronization therapy (CRT) responder rate can be improved by 3-dimensional (3D) echo-guided left ventricular (LV) lead placement compared to traditional LV lead placement.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be implanted with an FDA approved St. Jude Medical CRT-D device (i.e. PROMOTE® or newer devices with similar functionality)
- •Patients will have an approved indication per American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines for implantation of a CRT-D
- •Patients will receive a new implant or an upgrade from an existing pacemaker or Implantable Cardiovertor Defibrillator with no prior Left Ventricular lead placement
- •Patients must be in sinus rhythm at the time of enrollment visit and baseline measurements
排除标准
- •Persistent or permanent atrial fibrillation
- •Heart transplantation
- •Recent myocardial infarction (< 90 days)
- •Contra-indication to contrast agent
- •Are less than 18 years of age
- •Are pregnant
- •Are currently participating in a clinical investigation that includes an active treatment arm
- •Have a life expectancy of less than 6 months
研究组 & 干预措施
Control group
Patients will be implanted according to the standard of care with the LV lead in the traditional LV lead position.
3D echo-guided LV lead placement group
Information about left ventricular mechanical dyssynchrony and the location of the site of latest mechanical activation based on Real-Time 3-Dimensional Echocardiography (RT3DE) will be available to the physician at the time of implant. This location will be used as the target for optimal LV lead placement.
干预措施: 3D echo-guided LV lead placement (Procedure)
结局指标
主要结局
Responder Rate
时间窗: At 6 month follow-up
The responder rate is defined as the proportion of patients with reduction in end systolic volume greater than or equal to 15%. The primary endpoint is the responder rate.
次要结局
未报告次要终点