Right Versus Left Apical Transvenous Pacing for Patients With Preserved Left Ventricular Systolic Function (RIVELA) Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 36
- 试验地点
- 12
- 主要终点
- Reduction in LVEF
研究概览
简要总结
The purpose of this study is to compare chronic (1-year) effects on left ventricular ejection fraction resulting from transvenous pacing of the right ventricular apex (RVA) versus the left ventricular apex (LVA) in patients with preserved or mildly reduced left ventricular systolic function (>= 45%).
详细描述
It is well established that chronic right ventricular apical pacing has an adverse effect on left ventricular systolic function. An alternative is pacing the left ventricular apex, which has shown more favourable results in terms of left ventricular pump function than the RVA in small series. The left ventricular apex may be paced via the coronary sinus tributary (e.g. in the anterior cardiac vein). Our study will compare effects of these two pacing sites on left ventricular ejection fraction measured by 3D-echocardiography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Requirement for ventricular pacing according to current guidelines (including chronic atrial fibrillation)
- •Anticipated >=50% daily ventricular pacing
- •LVEF >=45% as evaluated by 2D-echocardiography, 3D-echocardiography, magnetic resonance imaging or by radionuclide/contrast ventriculography
- •Minimum age of 18 years, and at least 1 year life expectancy
排除标准
- •Prior tricuspid valve replacement (annuloplasty is permitted)
- •Intrinsic rhythm < 30bpm
- •Patients with permanent atrial fibrillation who undergo ablation of the atrioventricular node.
- •Echocardiographic window of insufficient quality for measuring LVEF
- •Life expectancy of < 1year
- •Pregnancy (women of childbearing potential will undergo pregnancy testing)
- •Unable of unwilling to sign a patient informed consent form
结局指标
主要结局
Reduction in LVEF
时间窗: baseline to one year
次要结局
- Change in left ventricular end-systolic and end-diastolic volumes(one year)
- Dyssynchrony evaluation during RV and LV pacing(one year)
- Change in tricuspid regurgitation severity, if any(one year)
- Change in mitral regurgitation severity, if any(one year)
- Incidence of device-related complications(one year)
- Success rate of autocapture algorithm for left-and right-ventricular pacing(one year)
- Mortality and all cause hospitalization(one year)
- Reduction of LVEF at 1 year compared to baseline according to the following pre-specified subgroups: a) initial LVEF, b) gender, c)etiology (coronary artery disease, nonischemic cardiomyopathy)(one year)
研究者
Haran Burri, MD
Assoc. Prof.
University Hospital, Geneva