NCT00551681已完成不适用
Effects of Left Ventricular Pacing Optimilization on Cardiac Perfusion, Contractile Force, and Clinical Performance in Patients With Ventricular Dysfunction and Heart Failure
R&D Cardiologie1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2007年11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
- 52
- 试验地点
- 1
- 主要终点
- Degree of change in cardiac perfusion following epicardial LV lead placement, compared to transvenous LV lead placement
研究概览
简要总结
To compare a surgical approach of LV lead placement for BIV pacing with the conventional transvenous approach by assessment of differences on the effects on cardiac perfusion and relate this to the clinical cardiac function.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart failure NYHA III or IV
- •QRS duration >120msec or, when paced > 200msec on 12-lead ECG
- •LBBB on ecg
- •LV ejection fraction 35% or less
- •LV dyssynchony on echocardiography
排除标准
- •Severe (drug refractory) heart failure with short (<6 months) life expectancy.
- •Permanent or persistent atrial fibrillation
- •Other indications for cardiac surgery within 6 months
- •Life expectancy less than one year due to other conditions
- •Major contra-indication for general anaesthesia
- •Participation in another study
- •Pregnancy or the desire to become pregnant during the follow up of the study.
研究组 & 干预措施
1
Active Comparator
Epicardial left ventricular lead placement
干预措施: biventricular pacemaker with epicardial left ventricular lead (Device)
2
Active Comparator
transvenous left ventricular lead
干预措施: transvenous left ventricular lead placement (Device)
结局指标
主要结局
Degree of change in cardiac perfusion following epicardial LV lead placement, compared to transvenous LV lead placement
时间窗: 6 months
次要结局
- Resynchronization of the LV, measured with TDI, 2D- and 3D-echocardiography, in patients with epicardial LV lead placement, compared to transvenous LV lead placement(6 months)
研究者
Vincent van Dijk
MD
R&D Cardiologie
研究点 (1)
Loading locations...
相似试验
撤回
不适用
Comparative Study to Examine Whether Echocardiography Performed During Cardiac Resynchronization Therapy Device Implantation Can Improve the Response RateEchocardiographyCardiac Resynchronization TherapyHeart FailureNCT01014000Princess Margaret Hospital, Hong Kong
已完成
不适用
CRT Implant Strategy Using the Longest Electrical Delay for Non-left Bundle Branch Block PatientsIschemic or Non-ischemic CardiomyopathyNon-left Bundle Branch BlockNCT01983293Abbott Medical Devices248
已完成
不适用
B-Left HF: Biventricular Versus Left Univentricular Pacing With Implantable Cardiac Defibrillator (ICD) Back-Up in Heart Failure PatientsVentricular DysfunctionHeart DiseasesHeart FailureNCT00187213Abbott Medical Devices
Unknown
不适用
Left Ventricular Pacing to Prevent Iatrogenic TR Pilot StudyTricuspid Valve InsufficiencySick Sinus SyndromeNCT02314897National University Hospital, Singapore20
终止
不适用
Right Versus Left Apical Transvenous Pacing for Patients With Preserved Left Ventricular Systolic Function StudyBradyarrhythmiaNCT01535404Haran Burri, MD36