More Options Available With a Quadripolar Left Ventricular (LV) Lead pRovidE In-clinic Solutions to Cardiac Resynchronization Therapy (CRT) Challenges
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,078
- 试验地点
- 64
- 主要终点
- Lead Performance
研究概览
简要总结
This investigation is designed with the hypothesis that using a quadripolar left ventricular lead results in less interventions when dealing with high pacing thresholds and Phrenic Nerve Stimulation (PNS), both at implant and during follow-up, compared to standard bipolar left ventricular leads.
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
- 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 are indicated for Cardiac Resynchronization Therapy with Defibrillation backup device (CRT-D) implantation, as per current international certified guidelines
- •Patients age is 18 years or greater
- •Patients must indicate their understanding of the study and willingness to participate by signing the appropriate informed consent form
- •Patients must be willing and able to comply with all study requirements
排除标准
- •Patients with a life expectancy <12 months.
- •Patients who are or may potentially be pregnant.
- •Patient has suffered any of the following in the 4 weeks prior to enrolment:
- •Myocardial Infarction (MI)
- •Coronary Artery Bypass Graft (CABG)
- •Unstable Angina Pectoris
- •Patient has primary valvular disease which has not been corrected
研究组 & 干预措施
BiP Group
Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)
干预措施: BiP Group (Procedure)
Quad Group
Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet
干预措施: Quad Group (Device)
结局指标
主要结局
Lead Performance
时间窗: 6 months
Percentage of patients with freedom from event (intra- and post-operative). Intra-operative events were defined as: need to use more than 1 left ventricular lead, need to change lead implant position, use of any device to actively fixate the lead, unsuccessful implant, due to phrenic nerve stimulation, high pacing threshold or lead instability. Post-operative events were defined as any left ventricular lead related serious adverse device effect and CRT switched off.
次要结局
- Implant Duration(Total duration of the implant procedure reported at the end of the procedure)
- Percentage of Cardiac Resynchronization Therapy Responders(Baseline and 6 months)