IntAct, Study on Promotion of Intrinsic Activity.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 150
- 试验地点
- 60
- 主要终点
- Calculation of reduction in % VP when RVP algorithm is ON versus OFF, recording % VP at 4 and 8 weeks after randomization
研究概览
简要总结
The purpose of this study is to provide evidence that the Refined Ventricular Pacing Algorithm leads to clinically relevant reduction (at least 50% reduction) of the incidence of ventricular pacing.
详细描述
Electrical stimulation in the apex of the right ventricle ( ventricular pacing) usually improves the heart function of patients with a pacemaker and can even be life-saving. However, evidence is accumulating that ventricular pacing may also have undesired long-term cardiac effects. Therefore, it makes sense to limit ventricular pacing to the absolute required minimum. The functionality RVP (Refined Ventricular Pacing) in the C-series 2nd generation pacemakers of Vitatron B.V. Arnhem, the Netherlands is designed to reduce ventricular pacing.
After implantation of the Vitatron C50 D model C50A2 (pacemaker) or Vitatron C60 DR model C60A2 (pacemaker) and a 4-6 weeks stabilization period, proper functioning of pacemaker and leads (stimulation- and sensing parameters) is checked. The pacemakers will be programmed according to predefined settings.
In the following 4-weeks Baseline period diagnostic data (atrial fibrillation burden and percentage of ventricular pacing (% VP)) are collected in the pacemaker memory. Based on these data, patients will be excluded from further participation (patients with more than 15% atrial fibrillation) or subdivided into three groups: (a) < 30% VP (30- VP group), (b) >30% VP, Sick Sinus Syndrome and normal conductivity (SSS group), (c) >30% VP, 1st or 2nd degree AV block. Patients in these three groups will be treated for 4 weeks alternatively with the RVP functionality switched ON or OFF. The order will be determined by randomization. At the end of these two cross-over periods the % VP and the judgment of the patients of the last period will be assessed. Adverse events will be recorded from the moment of study enrolment.
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
- Double
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 shall be willing to sign the Patient Informed Consent for this study
- •Patients shall have at least one of the following indications for a pacemaker: - Sick Sinus Syndrome with normal QRS complexes
- •First degree AV block with a PR interval <_220 ms for patients <_ 70 years of age, or <_ 260 for patients over 70 years
- •Second-degree AV block, mobitz I (wenckebach) or mobitz II
- •Patients shall be available for follow-up for the duration of their participation.
排除标准
- •Patients involved in another investigation study conducted in parallel to this study
- •Patients younger than 18 years of age and/or patients that do NOT meet other local requirements for participation
- •Pregnant patients
- •Patients with lead integrity problems (and the lead is not being replaced)
- •Patients with persistant AF
- •Patients with a complete AV block
- •Patients with NYHA (New York Heart Association0 class III and IV
- •Patients who underwent thoracic surgery in the last three months or are expected to have in the near future
- •Patients with a 2:1 block
- •Patients with a life expectancy less than half a year
结局指标
主要结局
Calculation of reduction in % VP when RVP algorithm is ON versus OFF, recording % VP at 4 and 8 weeks after randomization
次要结局
- Occurrence of possible undesired consequences of the RVP algorithm (e.g. retrograde conduction; AF burden) and adverse events in the periods with the algorithm switched ON versus OFF, 4 and 8 weeks after randomization
- Patient's opinion about treatment (on a six-point scale), at 4 and 8 weeks after randomization
- explorative subanalysis on patients with different arrhythmias and/or conducting system defects to investigate in which type of patients the RVP algorithm will have the largest impact on %VP
- Reproducibility of the %VP assessment, comparison %VP during Baseline periode and 4-week study period with RVP OFF