Effectiveness and Reliability of Selected Site Pacing for Avoidance of Phrenic Nerve Stimulation in CRT Patients With Quadripolar LV Leads
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 337
- 试验地点
- 16
- 主要终点
- Percentage of patients with at least one acceptable lead vector
研究概览
简要总结
Cardiac resynchronization (CRT) therapy is well established for treatment of patients with severe heartfailure, reduced left ventricular (LV) function and ventricular dyssynchrony. Roughly 1/3 of CRT patients do not improve after CRT implant. One possible reason is interruption of biventricular pacing. This might be caused by several conditions, including elevated left ventricular (LV) pacing thresholds or presence of phrenic nerve stimulation (PNS). CRT devices with quadripolar LV leads offer 10 LV pacing vectors to choose from. It's the aim of this prospective observational study to investigate efficacy and reliability of cardiac resynchronization therapy (CRT) with quadripolar left ventricular leads.
Hypothesis: In more than 90% of patients, who received a CRT system with quadripolar LV lead, at least one acceptable LV lead vector is available.
详细描述
Definition of an acceptable lead vector: Any LV pacing vector that complies in both tested body positions (left lateral position and sitting) with both criteria:
- Phrenic nerve stimulation threshold is at least twice as high as LV pacing threshold
- LV pacing threshold is less or equals 2.5Volts (V) @0.5 milliseconds (ms)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 implantation of a CRT-D
- •Age >= 18 years
- •Written informed consent
排除标准
- •Already implanted LV or coronary sinus lead
- •Previous unsuccessful LV lead implant attempt
- •Patient is eligible for heart transplantation
- •Comorbidities that results in life expectancy of less than 12 months
- •Known pregnancy
- •Inability to provide written patient informed consent
- •Participation to another study with active treatment arm (i.e. randomized studies etc...)
- •Patient is not willing or is not able to visit the study center for the study assessments within the first 3 months after implant
- •Patient is not able to understand or answer the quality of life questionaire
结局指标
主要结局
Percentage of patients with at least one acceptable lead vector
时间窗: Pre hospital discharge (PHD) to 3 months
Definition of acceptable lead vector: Any LV vector that complies in both tested body positions with both criteria: 1. Phrenic nerve stimulation threshold is at least twice as high as LV pacing threshold 2. LV pacing threshold is less or equals 2.5V@0.5ms
次要结局
- Quality of Life(Baseline to 3 months)
- Phrenic nerve stimulation (PNS)(PHD to 3 months)
- LV pacing thresholds(PHD to 3 months)
- Number of acceptable LV lead vectors per patient(PHD to 3 months)
- Finally programmed LV lead vector(PHD to 3 months)