International Ledless Pacemaker Registry (i-LEAPER)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 12
- 主要终点
- Upgrading with a different pacing system
研究概览
简要总结
The Micra MC1VR01 or Micra AVMC1AVR1 Transcatheter Pacing System (Medtronic, Inc., Minneapolis, MN, USA) has become a major breakthrough as an alternative to standard transvenous pacemakers.
The aim of this multi-center study is to assess the clinical outcomes of patients implanted with Micra LLPM in real life, in different clinical scenarios.
详细描述
The study includes consecutive patients implanted with a pacemaker leadless device (Micra Transcatheter Pacing System; Medtronic, Inc., Minneapolis, MN, USA).
Baselines characteristics, procedural and clinical outcomes will be collected and analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients implanted with the MIcra leadless pacing system
- •At least 1 month of follow up
- •At least 1 post-implantation assessment, in accordance to the routine clinical practice of every center
排除标准
- 未提供
结局指标
主要结局
Upgrading with a different pacing system
时间窗: Through study completion, an average of 2 years
Need of an additional transvenous pacing system
All cause mortality
时间窗: through study completion, an average of 2 years
overall mortality
Electrical performance of the pacing system
时间窗: Through study completion, an average of 2 years
pacing impedances values
Implant complication rates
时间窗: during and immediately after the intervention
Dislodgments, Cardiac perforation, vascular complications (access site).
次要结局
未报告次要终点
研究者
Giovanni B Forleo
Section Head Electrophysiology and Clinical Pacing
Luigi Sacco University Hospital