NCT00180284已完成3 期
SITELINE 2 Polyurethane Clinical Investigation
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Pacing voltage threshold at 3 Months
研究概览
简要总结
The SITELINE 2 Polyurethane Clinical Investigation analyzed the safety and electrical performance of the SITELINE 2 Polyurethane pacing lead.
详细描述
This was a prospective, single-arm, multi-center U.S. clinical investigation, designed to demonstrate the safety and effectiveness of the SITELINE 2 Polyurethane extendable, retractable pacing lead in humans
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 indicated for dual chamber pulse generator implant, where the pulse generator is capable of meeting the requirements of this investigational protocol
- •Patients selected must have the study lead as the initial implant of a permanent pacing lead in both the right atrium and the right ventricle
- •Age 18 or above, or of legal age to give informed consent specific to state and national law
- •Willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation
- •Available for follow-up at an approved clinical investigational center, at the protocol-defined intervals
- •A life expectancy of more than 180 days
排除标准
- •Have or who are likely to receive a mechanical tricuspid valve during the course of the clinical investigation
- •Have surgically uncorrected primary valvular heart disease
- •Have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) or persistent (i.e., can be terminated with medical intervention, but does not terminate spontaneously)
- •Requiring ICD therapy
- •Have a hypersensitivity to a nominal single dose of 1.0 mg (0.5 mg per electrode) of dexamethasone acetate drug
- •Enrolled in any concurrent study, including drug investigation, without Guidant written approval, that may confound the results of this study
- •Women who are pregnant or plan to become pregnant
结局指标
主要结局
Pacing voltage threshold at 3 Months
时间窗: 3 months
Pacing impedance at 3 Months
时间窗: 3 months
Sensed amplitude at 3 Months
时间窗: 3 months
Lead complication-free rate up to 3 Months
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (2)
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