NCT00559143撤回4 期
Better Pacing - Biventricular Pacing as Alternative Method in Patients With Disturbances of AV Conduction and Preserved LV Function
Medtronic Hellas Medical Devices ΑEE2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2007年11月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change in End Diastolic Diameter of Left Ventricle with the two different ways of pacing (DDD(R)-RV & DDD(R)-BiV)
研究概览
简要总结
Aim of present study is to examine the short and long-term results of pacing from right ventricular apex and to compare them with those of biventricular pacing.
详细描述
In this study all subjects to be studied will have atrioventricular conduction disturbances that require permanent artificial pacing. In all subjects a biventricular pacemaker will be implanted. Moreover the subjects will be randomized in a biventricular or conventional pacing mode and will be observed for a long term period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects between the age of 18 to 75 years with classic indication for permanent artificial pacing in which it is expected very high percentage of ventricular pacing, (pacing systoles constitute the 80% and more of the total).
- •Physiologic or mildly affected systolic function of left ventricle, LVEF> 40%.
- •Subject is willing and able to comply with the Clinical Investigational Plan and to remain available for follow-up visits, through study closure.
- •Subject (or if allowed by local law/regulations: subject's legally authorised representative) is willing and able to sign and date the study Informed Consent.
排除标准
- •Subjects with classic indication for Biventricular Pacing - (European Guidelines 2007).
- •Permanent atrial fibrillation.
- •Cardiovascular surgery within the last three months prior to enrollment.
- •Myocardial infarction within the last three months prior to enrollment.
结局指标
主要结局
Change in End Diastolic Diameter of Left Ventricle with the two different ways of pacing (DDD(R)-RV & DDD(R)-BiV)
时间窗: two years
次要结局
- Tolerance in the cardiopulmonary stress test, quality of life, LV function and changes of BNP, TNF, interleukin-6, interleukin-12 and oxidant stress.(two years)
- Assessment of the operation of Left Ventricle at the different pacing types using conductance catheters in a subgroup of patients that will perform a programmed coronary angiography due to investigation of possible coronary artery disease.(two years)
研究者
研究点 (2)
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