EnPulse Trial on Search AV+ Influence
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 135
- 试验地点
- 26
- 主要终点
- Amount of right ventricular pacing
研究概览
简要总结
Right ventricular apical pacing in patients treated with a pacemaker is unnecessary in cases where patients have stable atrioventricular (AV)-conduction. Recent findings demonstrate that pacing even might have unfavourable effects, especially if patients suffer from additional cardiac diseases such as heart failure. The Search AV+ algorithm was designed to avoid ventricular pacing and support intrinsic AV-conduction in order to avoid possible detrimental effects of right ventricular apical pacing. The goal of the EnTRINSIC study is to assess the amount of ventricular stimulation, the amount of hospitalizations, the occurrence of atrial fibrillation and the usage of drugs in patients treated with pacemakers with an activated Search AV+ algorithm versus patients treated with an individual optimization of the pacemaker settings to minimize the amount of right ventricular pacing.
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
- •Patients with sinus node disease and an intrinsic AV delay of maximal 260 ms
- •Patients treated with a Medtronic pacemaker with Search AV+ algorithm
排除标准
- •Patients with documented persistent atrial fibrillation within 6 months before implantation and slow AV-conduction
- •New York Heart Association (NYHA) III/IV
- •Instable angina pectoris
- •Heart valve vitium
- •Persistent AV-block II and III
- •Early diastolic mitral regurgitation
- •Implantable cardioverter defibrillator
- •Participation in other clinical studies
- •Pregnancy or unreliable birth control
- •AV-block under strain
结局指标
主要结局
Amount of right ventricular pacing
时间窗: Baseline to 36 months post-implant
次要结局
- Change in intrinsic AV delay(Baseline to 36 months post-implant)
- Medication(Baseline to 36 months post-implant)
- Hospitalizations because of symptomatic heart failure(Baseline to 36 months post-implant)
- Hospitalizations because of symptomatic atrial fibrillation(Baseline to 36 months post-implant)