VERRARI - "Are Ventricular Arrhythmic Episodes Reduced by Rate Response in ICDs?"
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- frequency of ventricular arrhythmias at 6 and 12 months follow ups
研究概览
简要总结
"The purpose of this study is to evaluate the influence of the rate response function of implantable cardioverter defibrillators (ICDs) on the frequency of ventricular arrhythmias in patients with an ICD."
详细描述
"Background: Studies have shown that bradycardia and irregular heart rates may increase the incidence of ventricular arrhythmias. Regularizing the heart rate and avoiding bradycardias by rate responsive pacing may be a way to reduce these arrhythmias.
This is a prospective, open-label, randomized multicenter study. Inclusion criteria: Patients with an indication for an ICD according to the AHA/ACC-guidelines who get a rate response system and have more than 5 % rate adaptive pacing during a one month screening phase may be included if they have given written informed consent. Rate adaptive pacing must not be contraindicated, patients must be able to perform a 6 min walk test, must not be NYHA IV and should have a life expectancy of more than 18 months.
Patients will be randomly assigned to 6 months of rate responsive pacing followed by 6 months of no rate responsive pacing, vice versa respectively. At 6 and 12 months follow ups, ICD stored data, arrhythmic episodes, medication, anamnesis, quality of life, 6 min walktest, echocardiographic parameters and optionally spiroergomatry will be evaluated and compared."
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
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
- 否
入选标准
- •indication for an ICD according to ACC/AHA guidelines
- •ICD with rate response function implanted
- •at least 5% rate response ventricular pacing during the one month screening phase
- •signed informed patient consent"
排除标准
- •rate responsive pacing contraindicated
- •patient not able to perform 6 min walktest
- •heart failure NYHA IV
- •life expectancy below 18 months"
结局指标
主要结局
frequency of ventricular arrhythmias at 6 and 12 months follow ups
次要结局
- medication, anamnesis, quality of life, 6 min walktest, echocardiographic parameters and optionally spiroergomatry at 6 and 12 months follow ups,