跳至主要内容
临床试验/NCT00457834
NCT00457834Unknown2 期

Study on the Efficacy of bi-Ventricular Pacing of Patients With Severe Heart Failure and Chronic Atrial Fibrillation

Umeå University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2003年11月1日最近更新:
适应症

试验速览

阶段
2 期
入组人数
40
试验地点
2
主要终点
quality of life

研究概览

简要总结

Cardiac resynchronization therapy (CRT) is used to treat dilated heart failure with discoordinate contraction. Dyssynchrony typically stems from electrical delay leading to mechanical delay between the septal and lateral walls. Right ventricular apical pacing might be associated with long-term adverse effects on left ventricular function, and alternative pacing sites such as high septal or RVOT has been suggested. Previous studies have however been conflicting. The aim of this study is to determine if bi-ventricular pacing from RVOT + LV is better than RVapex+LV. To avoid influence from possible atrial delay only patients with chronic atrial fibrillation are included. All patients will receive a bi-ventricular pacemaker with 3 leads placed in RVapex, RVOT and via coronary sinus to pace the left ventricle. After a run in period (to determine if AV-junction ablation is necessary) the patients are randomised to one of the following pacing configurations: RVOT+LV or RVapex+LV with cross-over after 3 month.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Heart failure NYHA III-IV
  • LVEF<35%
  • QRS duration>150 ms
  • Chronic atrial fibrillation.

排除标准

  • Heart failure not related to systolic function
  • Unstable angina pectoris, AMI, PCI or CABG within 2 month
  • Inclusion in other studies

结局指标

主要结局

quality of life

次要结局

  • NYHA class
  • 6-MWT
  • bi-cycle test
  • pro-BNP
  • echocardiographic measures
  • apnea-hypopnea index

研究者

申办方类型
Other

研究点 (2)

Loading locations...

相似试验