NCT00528307终止不适用
Changes in Myocardial Perfusion During Chronic Multi Site Biventricular Versus Right Ventricular Apex Pacing in Patients With Normal Left Ventricular Function Undergoing His Bundle Ablation for Drug-refractory Atrial Fibrillation
R&D Cardiologie1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2007年10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
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Difference in size of myocardial perfusion abnormalities in the two treatment groups as measured with MPS.
研究概览
简要总结
To determine whether Biventricular pacing in patients undergoing HIS bundle ablation for atrial fibrilation has beneficial effects on myocardial perfusion and left ventricularr ejection fraction.
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
- 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
- •Normal to nearly normal LVF (EF > 40%)
- •Drug-refractory, persistent or permanent atrial fibrillation
- •Referred for His ablation
排除标准
- •Unwilling or unable to sign the informed consent
- •Life expectancy < 1year from non-cardiac causes
- •Previous myocardial infarction
- •Previous coronary bypass surgery
- •Poor left ventricle function (EF< 40%) from any cause
- •Symptomatic obstructive coronary artery disease
- •Poor ultra sound imaging quality.
研究组 & 干预措施
1
Active Comparator
First 3 months of biventricular pacing, second 3 months right ventricular apical pacing
干预措施: HIS buldle ablation (Device)
2
Active Comparator
First 3 months of right ventricular apical pacing, second 3 months biventricular pacing
干预措施: HIS buldle ablation (Device)
结局指标
主要结局
Difference in size of myocardial perfusion abnormalities in the two treatment groups as measured with MPS.
时间窗: 6 months
次要结局
未报告次要终点
研究者
Vincent van Dijk
MD
R&D Cardiologie
研究点 (1)
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