NCT01454050已完成不适用
PME/Master Study of the Lumax 740 ICD Family
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- Efficacy of the automatic Capture Control feature
研究概览
简要总结
The objective of this study is to prove the safety and efficacy of the Lumax 740 ICD family. Primarily, the newly implemented RV/LV Capture Control algorithm is evaluated, which automatically measures the RV/LV threshold and subsequently adjusts the pacing output.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Inclusion Criteria: Standard indication for single, dual, or triple chamber ICD.
- •Legal capacity and ability to consent
- •Signed patient informed consent
- •In addition for HF-T devices:
- •Bipolar LV-lead with a min. distance of 15 mm between tip and ring
- •True bipolar RV lead
排除标准
- •Standard contraindication for single, dual, or triple chamber ICD.
- •Age < 18 years
- •Pregnant or breast-feeding woman
- •Cardiac surgery planned within the next 6 months
- •Life expectancy of less than 6 months
- •Participating in any other clinical study of an investigational cardiac drug or device
结局指标
主要结局
Efficacy of the automatic Capture Control feature
时间窗: PHD, 1-, 3- and 6-month follow-up
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Lumax DX / Linox DX EvaluationCardiac DiseaseNCT01486836Biotronik SE & Co. KG38
已完成
4 期
Linox Smart S DX PME/Master StudyICD IndicationNCT01090401Biotronik SE & Co. KG116
终止
不适用
Efficacy and Safety of Implantable Cardioverter-Defibrillator (ICD) Implantation in the ElderlyMyocardial InfarctionCoronary Artery DiseaseCongestive Heart FailureCardiomyopathyNCT02121158VA Office of Research and Development167
已完成
2 期
A Clinical Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne VulgarisAcne VulgarisNCT00666900Dow Pharmaceutical Sciences366
已完成
3 期
Efficacy and Safety of CDP870 Versus Placebo in the Treatment of the Signs and Symptoms of Rheumatoid ArthritisRheumatoid ArthritisNCT00548834UCB Pharma220