NCT01850264已完成不适用
Quartet™ Bad Oeynhausen Trial
Heart and Diabetes Center North-Rhine Westfalia2 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2013年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Reduction of New York Heart Association (NYHA) functional class
研究概览
简要总结
Primary objective of this study is to evaluate whether the use of a quadripolar left ventricular (LV) electrode compared to a standard bipolar LV electrode leads to lower non-responder rates in patients undergoing cardiac resynchronization therapy (CRT)
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for CRT-D implantation according to current guidelines
- •Ischemic cardiomyopathy (ICM) or dilated cardiomyopathy (DCM)
- •Sinus rhythm
- •NYHA II-IV
- •Age ≥ 18 years
- •Written informed consent to participate in the study
排除标准
- •Right bundle brunch block
- •Valvular cardiomyopathy
- •Patient receiving a non-transvenous LV electrode
- •Known pregnancy
- •Age < 18 years
- •Life expectancy < 1 year
- •Atrial fibrillation / atrial flutter at the time of enrolment
- •Inability to provide informed consent
- •Participation in another study with active therapeutic arm
- •Regular follow-up in the study center within the first 6 months after implantation not guaranteed
研究组 & 干预措施
Bipolar LV electrode
Active Comparator
Application of a bipolar LV electrode
干预措施: Application of quadripolar / bipolar LV electrodes (Device)
Quadripolar LV electrode
Active Comparator
Application of a quadripolar LV electrode
干预措施: Application of quadripolar / bipolar LV electrodes (Device)
结局指标
主要结局
Reduction of New York Heart Association (NYHA) functional class
时间窗: 6 months
Increase in peak oxygen consumption
时间窗: 6 months
Survival
时间窗: 6 months
次要结局
未报告次要终点
研究者
Klaus Juergen Gutleben
Senior cardiologist
Heart and Diabetes Center North-Rhine Westfalia
研究点 (2)
Loading locations...
相似试验
已完成
不适用
More Options Available With a Quadripolar LV Lead pRovidE In-clinic Solutions to CRT ChallengesPostoperative Cardiac ComplicationLeft Ventricular Cardiac DysfunctionInappropriate Phrenic Nerve StimulationHeart FailurePerioperative/Postoperative ComplicationsNCT01510652Abbott Medical Devices1,078
已完成
不适用
LV Only MPP With SyncAVLeft Bundle-Branch BlockHeart FailureNCT03567096Abbott Medical Devices101
已完成
4 期
Multisite Pacing With a Quadripolar LeadHeart FailureNCT00964938Abbott Medical Devices35
招募中
不适用
Multimodality Evaluation of Left Ventricular Remodeling In Mitral Regurgitation: A Pilot StudyLeft Ventricular Systolic DysfunctionNCT06770062Mayo Clinic30
已完成
不适用
Promote Q Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Quartet Left Ventricular Heart Lead StudyHeart FailureNCT00990665Abbott Medical Devices178