NCT05958836尚未招募不适用
Quality of Life and Clinical Outcomes in Patients Treated With Leadless Micra Transcatheter Pacemakers as Compared With Traditional Transvenous Pacemakers
Shanghai Zhongshan Hospital0 个研究点目标入组 246 人开始时间: 2023年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 246
- 主要终点
- Health-related quality of life measured by NHP (Nottingham Health Profile)
研究概览
简要总结
The study aims to carry out a domestic multi-center, prospective, non-randomized, non-blinded post-approval study to assess health-related QoL between Micra TPS and conventional PM implantation. Meanwhile, pocket and leads related complications would also be evaluated between these two strategies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- 是
入选标准
- •With an age arranged from 18 to 80 years old;
- •Conforming to indication of a pacemaker implantation;
- •Life expectancy>1 year;
- •Normal cardiac function with preserved LVEF;
- •Adequate self-care ability or self-help skills before pacemaker implantation;
- •Mentally healthy so as to participate in the quality-of-life assessments;
- •Willing to participate in study through consent and willing to undergo study specific required procedures with expectancy of geographically stable for follow up duration.
排除标准
- •Subject with indication for ICD/ CRT-P/CRT-D;
- •Subject with persistent symptomatic sinus bradycardia;
- •Subject has an existing or prior pacemaker, ICD or CRT device implant;
- •Subject has unstable angina pectoris or has an acute myocardial infarction (AMI) in the 30 days prior to eligibility assessment;
- •Subjects with a mechanical tricuspid valve, implanted vena cava filter, or left ventricular assist device (LVAD);
- •Subjects with a life expectancy of less than 12-months;
- •Subjects with medical condition which precludes patient from participation in the opinion of the investigator, such as arthritis, lung disease or previous stroke, renal dysfunction, recent major surgery within six months, clinically overt congestive heart failure;
- •Pregnant women or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth regulation method or abstinence;
- •Psychological disorders unable to participate in the quality-of-life assessments.
结局指标
主要结局
Health-related quality of life measured by NHP (Nottingham Health Profile)
时间窗: 6 Months post implant
The NHP results shall be collected during study follow up visits
Health-related quality of life measured by EQ-5D-5L
时间窗: 6 Months post implant
The EQ-5D-5L results shall be collected during study follow up visits
次要结局
未报告次要终点
研究者
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