Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 324
- 试验地点
- 2
- 主要终点
- Worsening of tricuspid regurgitation by at least one grade
研究概览
简要总结
This is the first randomized controlled trial comparing transesophageal echocardiography + fluoroscopy guided lead implantation vs. standard lead implantation guided by fluoroscopy only. Patients are randomized 1:1 in the two groups and followed up for up to 3 years.
详细描述
Lead-induced tricuspid regurgitation is a frequent complication after pacemaker- and ICD-implantation that is associated with increased mortality and hospitalizations for heart failure. Transesophageal echocardiography has shown to be a safe and feasible way to guide right ventricular lead placement and was associated with less worsening of tricuspid regurgitation than standard lead implantation in a small study with a retrospective control group. This is the first randomized controlled trial comparing transesophageal echocardiography + fluoroscopy guided lead implantation vs. standard lead implantation guided by fluoroscopy only. Patients are randomized 1:1 in the two groups and followed up for up to 3 years. Echocardiographic grading of the primary endpoint will be performed by a blinded echocardiographer according to current guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •indication for right ventricular lead implantation according to current guidelines
排除标准
- •preexisting tricuspid regurgitation ≥ grade 2
- •other severe heart valve disease
- •history of tricuspid valve treatment
- •preexisting right ventricular lead
- •chronic dialysis
- •contraindication for transesophageal echocardiography
结局指标
主要结局
Worsening of tricuspid regurgitation by at least one grade
时间窗: Mean follow up of 2 years
Worsening of tricuspid regurgitation by at least one grade on transthoracic echocardiography according to current guidelines
次要结局
- Death and cardiovascular death(Mean follow up of 2 years)
- Heart failure hospitalizations(Mean follow up of 2 years)
- Duration of procedure and radiation(Mean follow up of 2 years)
- Right ventricular function and geometry as assessed by transthoracic echocardiography(Mean follow up of 2 years)
- Sensing, Pacing and RV-stimulation of the right ventricular lead(Mean follow up of 2 years)
- Change in functional capacity as assessed NYHA classification(Mean follow up of 2 years)
- Change in quality of life as assessed by MLHFQ(Mean follow up of 2 years)
研究者
Daniel Braun, MD
Senior attending physician department of cardiology, principal investigator
LMU Klinikum