MODULA-Study: Modul 7 VRR: Correlation Between Ventricular Rate Regulation (VRR) and the Percentage of Biventricular Pacing as Well as Subjective Quality of Life and Level of Physical Ability in CRT Patients With Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Percentage of Biventricular Pacing
研究概览
简要总结
This study will look at the correlation between ventricular rate regulation (VRR) and the percentage of biventricular pacing as well as subjective quality of life and level of physical ability in CRT patients with atrial fibrillation.
详细描述
To investigate whether VRR can increase the amount of biventricular pacing in CRT patients with conducted atrial arrhythmias. Secondarily, an investigation will be carried out to determine whether this increase in biventricular pacing results in an improvement in quality of life, as well as an improvement in the symptoms caused by the atrial arrhythmia and an improvement in the level of physical ability.
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
- Single (Participant)
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
- •Patients with CRT system with the VRR algorithm
- •Patients with permanent atrial fibrillation
- •Occasional conducted atrial fibrillation resulting in ventricular rates > 70 beats per minute (bpm)
- •QRS complex > 120 ms
排除标准
- •Patients with third degree atrioventricular (AV) block
结局指标
主要结局
Percentage of Biventricular Pacing
时间窗: 6 month
Comparison of the average percentage of biventricular pacing in subjects randomised to Ventricular Rate Regulation (VRR) = ON to subjects randomized to VRR = OFF
次要结局
- Correlation Between VRR and the Subjective Quality of Life(6 Month)
- Correlation Between VRR and Physical Ability (6 Minute Walk Test, Optional Spiroergometry)(6 months)
- Correlation Between VRR and the Symptoms Caused by Conducted Atrial Arrhythmias(6 months)