NCT01731210终止2 期
Clinical Evaluation Of The Nano Lv Lead System In Chronic Situation
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- LivaNova
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Freedom from left ventricular lead related complications through 1 month
研究概览
简要总结
The LENEA study is an international, prospective, open label, non-randomized multicenter clinical research study designed to assess the safety and effectiveness of the NANO LV lead system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D system for treatment of heart failure or life threatening ventricular tachyarrhythmia(s)
- •Receiving a new implant OR undergoing an upgrade from an existing ICD or pacemaker implant with no prior implanted LV lead OR undergoing a new LV implant attempt consecutive to a recent LV lead placement failure not related to coronary sinus cannulation failure
- •Patient receiving the PARADYM RF CRT or PARADYM RF CRT SONR devices
- •Ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations
排除标准
- •Ventricular tachyarrhythmia of transient or reversible causes such as acute myocardial infarction, digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia or sepsis, uncorrected at the time of the enrolment;
- •Incessant Ventricular tachyarrhythmias;
- •Unstable angina, or acute MI , CABG , or PTCA within the past 4 weeks;
- •Correctable valvular disease that is the primary cause of heart failure;
- •Post heart transplant (patients who are waiting for a heart transplant are allowed in the study);
- •Patient who had previously a permanently implanted LV lead;
- •Concurrent implant with another pacemaker or ICD (previously implanted pacemaker or ICD devices should be removed prior to implant with the Paradym RF CRT-D or Paradym RF CRT SONR);
- •Already included in another clinical study that could confound the results of this study;
- •Life expectancy less than 1 year.
结局指标
主要结局
Freedom from left ventricular lead related complications through 1 month
时间窗: 1 month
次要结局
未报告次要终点
研究者
研究点 (2)
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