EVITA: Evaluation of VIP Feature in Pacemaker Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 461
- 试验地点
- 4
- 主要终点
- Percentage of ventricular pacing
研究概览
简要总结
The primary efficacy objective of this clinical investigation is to demonstrate that the Ventricular Intrinsic Preference (VIP™) feature allows to reduce the medium- and long-term incidence of unnecessary ventricular pacing in patients with intact AV conduction.
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
- •Patient has an indication for implantation of a dual-chamber pacemaker;
- •Patient is implanted or scheduled to be implanted with a St Jude Medical Victory pacemaker, or newer device with the same study relevant feature.
排除标准
- •Patient has persistent or permanent AF/AFl;
- •Patient has permanent AV Block;
- •Patient has a pacemaker replacement;
- •Patient is in NYHA class IV;
- •Patient is unable to attend the follow-up visits;
- •Patient is pregnant;
- •Patient is less than 18 years of age
研究组 & 干预措施
2
Ventricular Instrinsic Preference (VIP) turned OFF
干预措施: Device: St. Jude Medical Victory dual-chamber pacemaker (Device)
2
Ventricular Instrinsic Preference (VIP) turned OFF
干预措施: Ventricular Intrinsic Preference (Device)
1
Ventricular Instrinsic Preference (VIP) turned ON
干预措施: Device: St. Jude Medical Victory dual-chamber pacemaker (Device)
1
Ventricular Instrinsic Preference (VIP) turned ON
干预措施: Ventricular Intrinsic Preference (Device)
结局指标
主要结局
Percentage of ventricular pacing
时间窗: 6 and 12 months
次要结局
未报告次要终点