NCT00795873已完成不适用
OVATIO CRT and SITUS OTW LV Lead Post Approval Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,260
- 试验地点
- 33
- 主要终点
- SITUS OTW LV lead complication free rate
研究概览
简要总结
Post approval study measuring safety outcomes on the Ovatio CRT-D and SITUS OTW LV lead over 5 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •NYHA Class III/IV
- •Stable medical regimen
- •QRS greater than or equal to 130 ms
- •LVEF less than or equal to 35%
排除标准
- •VT of transient or reversible causes
- •Incessant VT
- •Currently implanted with a lead positioned through the coronary sinus (unless it is the SITUS OTW LV lead)
- •Cardiac revascularization or angioplasty within the last month
- •Heart failure due to correctable valve disease
- •Chronic, medially refractory AT
- •Enrolled in another clinical study that may confound the results of this study
- •Life expectancy less than 6 months
- •Inability to understand the purpose of the study or refusal to cooperate
- •Inability or refusal to provide informed consent
- •Unavailable for scheduled follow-up with the implanting practice
- •Sensitivity to 1 mg dexamethasone sodium phosphate
- •Less than 18 years of age
- •Pregnancy
结局指标
主要结局
SITUS OTW LV lead complication free rate
时间窗: 5 years
次要结局
- System complication free rate(6 months)
研究者
研究点 (33)
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