NCT00180336已完成2 期
CONTAK RENEWAL 4 AVT Field Following
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- System Complication-Free Rate at 6 months
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of the CONTAK RENEWAL 4 AVT device.
详细描述
This is a prospective, two-arm, non-randomized, multi-center European field following, designed to demonstrate the safety and effectiveness of the CONTAK RENEWAL 4 AVT device in humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Indications for the device
- •Availability for follow-up at an approved Field Following center, at the protocol defined intervals
- •Willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation
- •Prescribed to stable optimal pharmacologic therapy for HF
- •Age 18 or above, or of legal age to give informed consent specific to national law
- •Able to provide documented evidence of one or more episodes of AF/AT within 12 months of implantation NOTE: Guidant recommends anticoagulation therapy per physician discretion.
排除标准
- •Right bundle branch block morphology
- •Life expectancy of less than six months due to other medical conditions
- •Expectation of a heart transplant during the period of the study
- •Patients with or who are likely to receive a mechanical tricuspid valve during the course of the study
- •Have a preexisting unipolar pacemaker that will not be explanted/abandoned
- •Have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) within 180 days prior to enrollment
- •Have a known hypersensitivity to dexamethasone acetate
- •Enrolled in any other study, including drug investigation
- •Women that are pregnant or planning to become pregnant
- •A Cerebral Vascular Event/ Transient Ischemic Attack within 12 months of implantation
- •During the four weeks prior to implantation, a patient experiences an episode of AF >= 48 hours in duration and was not anticoagulated for at an adequate therapeutic level (INR >= 2.0) for the 4 weeks prior to enrollment
结局指标
主要结局
System Complication-Free Rate at 6 months
Effectiveness of LV Only/LV Offset at 6 months
次要结局
- LVESD at 6 months
- Six-minute walk at 6 months
- NYHA at 6 months
- QOL at 6 months
研究者
研究点 (2)
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