Electronic Repositioning With Acuity and Easytrak Leads
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 305
- 试验地点
- 2
- 主要终点
- Proportion of Patients Without the Occurrence of Cardiac Resynchronization Therapy (CRT)-Induced Phrenic Nerve Stimulation (PNS) Between Implant and First Regular Follow-up (FU)
研究概览
简要总结
Evaluate appropriate performance of Electronic Repositioning™ (ER) in the clinical routine, cumulative incidence of phrenic nerve stimulation (PNS) & success rates of Electronic Repositioning (ER) to remove it, various incl. left ventricular pacing (LVP) thresholds and PNS
详细描述
Bipolar leads for left ventricular pacing (LVP) such as the newly available ACUITY™ or the standard EASYTRAK™ II and EASYTRAK™ III leads from GUIDANT in combination with suitable devices for cardiac resynchronization therapy (CRT) allow for the non-invasive programming of different Left Ventricular Pacing (LVP) configurations. Hence, this Electronic Repositioning (ER) may help physicians to overcome problems in cardiac resynchronization therapy (CRT) such as ineffective biventricular pacing, high Left Ventricular Pacing (LVP) thresholds and phrenic nerve stimulation (PNS) without the need for an additional patient's operation to reposition LV leads. The ERACE study it a multi-center, prospective, non-randomized clinical study to document and evaluate appropriate performance of GUIDANT's Electronic Repositioning™ in the clinical routine with respect to the following major aspects:
avoidance of PNS and low LVP thresholds (for low battery consumption and extended device longevity) in standard cardiac resynchronization therapy (CRT)
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
- 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
- •Patients receiving their FIRST implantation of a Left Ventricular (LV) lead in combination with a CRT device with implantable cardioverter defibrillator (ICD) backup and the possibility for Electronic Repositioning™
- •Patients willing (= signed written consent) and capable to participate in all procedures of the study"
排除标准
- •Patients who will not be available for routine Follow up
- •18 years old
- •Known pregnancy.
结局指标
主要结局
Proportion of Patients Without the Occurrence of Cardiac Resynchronization Therapy (CRT)-Induced Phrenic Nerve Stimulation (PNS) Between Implant and First Regular Follow-up (FU)
时间窗: From implant until first follow up (occurred between 3 or 6 month after implant procedure)
The primary endpoint was the percentage of patients in whom PNS induced by Left Ventricular (LV) pacing could be avoided by electronic repositioning from implantation to first regular follow up (3-6 months postimplant). In this evaluation, prevention of PNS was defined as PNS appearing with the standard pacing configuration-LV tip as cathode versus Right Ventricle (RV) coil as anode-and being avoided by at least one of the three alternative reprogrammable configurations.
次要结局
未报告次要终点