Effects of Different Right Ventricular Lead Positioning on Cardiac Contraction Measured by Cardiac MRI: a Pilot Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Ejection Fraction
研究概览
简要总结
Chronic right ventricular apical pacing has been associated with negative hemodynamic effects. Clinical outcome of right ventricular pacing can be influenced by multiple factors. An important factor seems to be optimal lead positioning. Data regarding left ventricular function impaired by lead positioning is insufficient. The aim of the present study therefore is to compare right ventricular apical pacing (RVAP) with right ventricular septal pacing (RVSP). Outcome measurements are echocardiographic features, magnetic resonance imaging and clinical outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with dysrhythmia requiring dual-chamber pacemaker implantation
- •planed MRI-pacemaker implantation (Accent MRI System,St. Jude Medical)
- •age between 18-90 years
- •no absolute pacemaker dependence
- •no present heart failure or any significant coronary heart disease (exclusion by anamnesis and echocardiography - LVH <15mm, LV EF>50%)
- •no previous myocardial infarction or significant coronary artery disease
- •life expectancy > 1 year
- •patients willing to participate in follow-up
排除标准
- •Contraindications for MRI (Brain aneurysm clips, artificial heart valves, artificial joints, vascular stents)
- •Any contraindication for surgery
- •Absolute pacemaker dependence
- •Claustrophobia
- •GFR<30ml/min/1,73m2
- •Allergy to contrast agent
研究组 & 干预措施
RVAP lead
Pacemaker lead implantation:
Pacemaker leads will be placed in specific predefined RA and RV sites according to randomization. In this arm pacemaker leads will be placed in the RV apex. The successful lead positioning at its target location will be verified by surface ECG and by fluoroscopy.
干预措施: RVAP (Other)
RVSP arm
Pacemaker lead implantation:
Pacemaker leads will be placed in specific predefined RA and RV sites according to randomization. In this arm pacemaker leads will be placed in the RV septum. The successful lead positioning at its target location will be verified by surface ECG and by fluoroscopy.
干预措施: RVSP (Other)
结局指标
主要结局
Ejection Fraction
时间窗: 6 month
As primary endpoint the difference of ventricular function in both groups will be taken. Therefore the Ejection Fraction is measured in cardiac MRI and Echocardiography. There may be a different development of contraction, whether the lead is placed in the ventricular apex or the ventricular septum.
次要结局
未报告次要终点
研究者
Alfred A Kocher, MD
MD., Prof.
Medical University of Vienna