QuickFlex® μ Model 1258T Left Heart Pacing Lead Post Approval Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,930
- 试验地点
- 77
- 主要终点
- Percent of Participants Alive and Without a Left Ventricular Lead-related Complication
研究概览
简要总结
The purpose of this multicenter post-approval study is to evaluate the acute and chronic performance of the QuickFlex® μ 1258T left ventricular (LV) lead.
详细描述
The primary endpoints of the study are:
- Freedom from LV lead-related complications at 5 years
- LV bipolar capture threshold of St. Jude Medical's QuickFlex®µ 1258T LV Lead measured at 0.5 ms at 5 years
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
- •Have an approved indication per American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines for implantation of a CRT-D system or participated in the QuickFlex® μ1258T (Investigational Device Exemption (IDE) study
- •Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations
排除标准
- •Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin
- •Have a life expectancy of less than 5 years due to any condition
- •Be less than 18 years of age
结局指标
主要结局
Percent of Participants Alive and Without a Left Ventricular Lead-related Complication
时间窗: 5 years
Percent of Participants Alive and Without a Left Ventricular Lead-related Complication at 5 years of follow-up. Per FDA, data from IDE subjects who did not consent to rollover into the post approval study at sites participating in the post approval study, were included in this analysis (see clinical investigational protocol).
Left Ventricular Bipolar Pacing Capture Threshold
时间窗: 5 years
Mean left ventricular bipolar pacing capture threshold measured at 0.5 ms pulse width at 5 years of follow-up
次要结局
未报告次要终点