Real-Time Intracardiac Impedograms of Left Ventricular Leads to Locate Sites of Latest Mechanical Delay in Cardiac Resynchronization Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Anatomic correlation between largest Ts (see description) and site of longest delay among probed locations in the CMR dyssynchrony map.
研究概览
简要总结
Despite the dramatic effect of cardiac resynchronization therapy (CRT) on survival and morbidity in people with congestive heart failure, 50-70% of eligible patients do not respond to this intervention. There is retrospective evidence that placement of the left ventricular (LV) lead at the region of latest mechanical delay markedly improves response to CRT. However, there is no feasible way to gauge dyssynchrony at LV lead sites during CRT implantation. Impedance recordings from pacing lead tips allow for real-time assessment of mechanical motion and may represent a useful intraoperative tool to guide optimum placement of the LV lead during CRT implantation. This pilot trial will assess the use of intraoperative impedograms in humans to measure regional dyssynchrony at potential LV lead locations during CRT implantation.
详细描述
This is a clinical trial using intracardiac impedance signals (impedograms) to assess regional dyssynchrony at various sites of left ventricular (LV) lead placement in humans undergoing CRT device implantation. This study will test the following hypotheses during the funding period:
- LV lead impedograms as an implant tool to place leads at sites of latest mechanical delay are feasible and correlate with other means of assessing dyssynchrony.
- LV lead impedograms vary significantly depending on LV lead location.
- There are several characteristics of LV lead impedograms that correlate with mechanical phenomena of the heart.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with NYHA class III or IV heart failure
- •LVEF ≤ 30%
- •QRS duration ≥ 120 ms
排除标准
- •Not a candidate for CRT implantation
结局指标
主要结局
Anatomic correlation between largest Ts (see description) and site of longest delay among probed locations in the CMR dyssynchrony map.
时间窗: Acute intraoperative measurement
Parameter will be recorded for at least 10 consecutive heartbeats during sinus and RV paced rhythm Ts = The average time from the sensed RV IEGM to the peak of the LV impedance curve
次要结局
- Differential correlation of Ts, Tp, and Td (see description) to the CMR dyssynchrony map.(Acute intraoperative measurement)