跳至主要内容
临床试验/NCT00528307
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

发起方
R&D Cardiologie
申办方类型
Other
责任方
Principal Investigator
主要研究者

Vincent van Dijk

MD

R&D Cardiologie

研究点 (1)

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