Multicenter, Prospective Evaluation of Performance, Safety, and Surveillance of the WiCS-LV System in Patients Indicated for Cardiac Resynchronization Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 10
- 主要终点
- Number of patients with device-related adverse events as a measure of safety
研究概览
简要总结
The WiCS-LV system is an alternative means to providing left ventricular stimulation for Cardiac Resynchronization Therapy (CRT). The purpose of this study is to evaluate the safety and performance of the WiCS-LV System in patients with indications for CRT.
详细描述
Eligible patients will undergo an acoustic window assessment using transthoracic echocardiography. Patients with adequate acoustic windows will undergo implantation of the WiCS-LV system.
Patients will undergo evaluations pre-hospital discharge, and at one month, 3 months, and 6 months post implantation. Extended follow-up will be obtained via a registry at 1, 2, 3, 4, and 5 years post implantation.
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 with standard indication for CRT based upon the most recent guidelines AND meeting criteria for one of these three categories:
- •Patients with previously implanted pacemakers or ICD's and meeting standard indications for CRT - referred to as "upgrades"
- •Patients in whom attempted coronary sinus lead implantation for CRT has failed - referred to as "untreated"
- •Patients with previously implanted CRT device, not responding to CRT (no change or worsening of symptom or NYHA functional class after 6 months of treatment confirmed by investigator) - referred to as "non-responders"
排除标准
- •Inability to comply with the study follow-up or other study requirements
- •Contraindication to heparin
- •Contraindication to both chronic anticoagulants and antiplatelet agents
- •Contraindication to iodinated contrast agents
- •Intracardiac thrombus by transesophageal echocardiography
- •Age less than 18 years
- •Attempted IPG implant within 3 days
- •Life expectancy of < 12 months
- •Chronic hemodialysis
- •Myocardial infarction within one month
- •Major cardiac surgery within one month
- •Female of childbearing potential, pregnant, or breastfeeding
- •Noncardiac implanted electrical stimulation therapy devices
结局指标
主要结局
Number of patients with device-related adverse events as a measure of safety
时间窗: 24 hour peri-operative and one month
Device-related adverse events are those in which the WiCS-LV system is directly or indirectly responsible.
Number of patients with procedure-related adverse events as a measure of safety
时间窗: 24 hour perioperative and one month
Procedure-related adverse events are those which occur during the WiCS-LV system implant procedure.
Bi-ventricular pacing capture
时间窗: one month
Bi-ventricular pacing capture documented on 12-lead EKG
次要结局
- Number of patients with device-related adverse events as a measure of safety(6 months)
- Number of patients with serious adverse events as a measure of safety(6 months)
- Left ventricular pacing capture(1, 3, and 6 months)
- Bi-ventricular pacing capture(1, 3, and 6 months)
- Clinical composite score(6 months)
- Change in echocardiographic indices(6 months)
- Change in blood laboratory Brain Natriuretic Peptide(6 months)