Post-market Study of Multi-Vector Left Ventricular Lead Performance in Chinese Patients With Chronic Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 14
- 主要终点
- The Number of Participants With LV Lead-related Serious Adverse Device Effects (SADEs)
研究概览
简要总结
The purpose of this clinical study is to observe the safety and efficacy of the multi-vector left ventricular (LV) lead in Chinese patients that are indicated for Cardiac Resynchronization Therapy (CRT).
详细描述
This is a multi-center, non-randomized observational study.
The total duration of the study is expected to be 2.5 years. The clinical study will be conducted in no more than 15 centers in China. Approximately 120 subjects will be enrolled in this study. Subjects will be followed up at 3, 6, 12 months and every 6 months afterwards. All subjects need to be followed for at least 6 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •Meets the current European Society of Cardiology (ESC) or American College of Cardiology Foundation (ACCF)/American Heart Association (AHA)/Heart Rhythm Society (HRS) Class I or Class IIa indications for CRT implant (including upgrades from single or dual chamber Implantable Cardioverter-Defibrillators (ICDs))
- •Are ≥ 18 years of age at the time of enrolment.
- •Are able to provide written Informed Consent prior to any study related procedure.
排除标准
- •Patient who is unable to comply with the follow-up schedule.
- •Patient who has any medical conditions that in the opinion of the investigator will not be appropriate to participate in the study .
- •Patient has a life expectancy of less than 1 year due to any condition.
- •Patients, who has a CRT device implanted
结局指标
主要结局
The Number of Participants With LV Lead-related Serious Adverse Device Effects (SADEs)
时间窗: From implantation to 6 months after implant procedure.
The primary safety endpoint is the number of participants with LV lead-related SADEs compared to the total number of analyzed participants.
次要结局
- The Intrinsic QRS Duration of Participants(6 months)
- The Number of Participants With Effective LV Pacing(6 months)
- The Number of Participants in Each NYHA Functional Class(6 months)