Leadless Pacemaker Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Procedural success rate
研究概览
简要总结
The registry for leadless pacemakers will collect and annually analyze the data of all leadless pacemaker implantations at the University Hospital St. Pölten, including demographic information, indications, procedural details, acute, medium- and long-term complications during follow-up. Due to the partially novel nature of the signals (atrial mechanical sensing markers) and the lack of long-term experience to date, data on these aspects will also be collected and analyzed.
This is a single-center, prospective and retrospective registry that includes all patients receiving a leadless pacing device, as well as all patients who received a leadless pacing device between January 2021 and the start of the registry. All patients undergoing implantation of a leadless pacemaker will be invited to participate in the registry. For patients to be included retrospectively, participation in the registry will be offered at the time of their next routine follow-up visit.
The indication for leadless pacing will be determined by the physician responsible for the patient. Enrollment in the registry will in no case alter or influence the treatment the patient receives. Data collection will take place at the time of implantation and continuously during follow-up over the entire study period. Pacemaker-related data may be obtained either in person or via remote monitoring.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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 undergoing implantation of a leadless pacemaker at the University Hospital of St. Pölten
- •Patients who previously received a leadless pacemaker between June 2015 and the start of the registry (retrospective inclusion).
- •Age ≥ 18 years.
- •Written informed consent provided by the patient.
排除标准
- •Patients who decline or are unable to provide informed consent.
- •Patients in whom a conventional transvenous pacemaker is implanted (i.e., not leadless).
- •Any condition that, in the opinion of the treating physician, precludes participation in the registry.
结局指标
主要结局
Procedural success rate
时间窗: Periprocedural / at Day 1
Successful implantation of a leadless pacemaker with acceptable electrical parameters and no need for conversion to a transvenous system
Incidence of acute complications
时间窗: Within 30 days after implantation
Rate of periprocedural complications (e.g., vascular complications, arrhythmias, pericardial effusion, device dislodgement)
次要结局
- All-cause mortality(Throughout follow-up (up to 10 years))
- Hospitalizations related to cardiac arrhythmias or heart failure(Throughout follow-up (up to 10 years))
- Left ventricular dimensions on Echocardiography(1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter)
- Right ventricular function on Echocardiography(1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter)
- Device-related complication rate (medium- and long-term)(Up to 10 years after implantation)
- Ventricular pacing burden(Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter)
- Quality of Life after Implantation(1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter)
- Electrical performance of the device(Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter)
- Left ventricular ejection fraction on Echocardiography(1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter)