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无导线起搏器注册研究：圣珀尔滕大学医院的结局与随访 (LPR)

2026年11月4日 更新者：Karl Landsteiner University of Health Sciences

无导线起搏器注册表

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.

研究概览

地位

招聘中

条件

研究类型

观察性的

注册 (估计的)

700

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 奥地利
    • Lower Austria
      • Sankt Pölten、Lower Austria、奥地利、3100
        • 招聘中
        • University Hospital of St. Pölten
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

The study population consists of adult patients undergoing implantation of a leadless pacemaker at University Hospital St. Pölten, as well as patients who previously received a leadless pacemaker at the same institution since June 2015. Both prospective and retrospective patients are included.

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：COHORT
  • 时间观点：OTHER

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Procedural success rate
大体时间：Periprocedural / at Day 1

Successful implantation of a leadless pacemaker with acceptable electrical parameters and no need for conversion to a transvenous system
Periprocedural / at Day 1
Incidence of acute complications
大体时间：Within 30 days after implantation

Rate of periprocedural complications (e.g., vascular complications, arrhythmias, pericardial effusion, device dislodgement)
Within 30 days after implantation

次要结果测量

结果测量
措施说明
大体时间
全因死亡率
大体时间：在整个随访期间（最长10年）
在整个随访期间（最长10年）
与心律失常或心力衰竭相关的住院治疗
大体时间：在整个随访期间（最长10年）
在整个随访期间（最长10年）
Device-related complication rate (medium- and long-term)
大体时间：Up to 10 years after implantation

Cumulative incidence of complications requiring medical or surgical intervention (e.g., device malfunction, infection, need for extraction, upgrade)
Up to 10 years after implantation
Ventricular pacing burden
大体时间：Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter

Percentage of ventricular pacing and triggered pacing as recorded by device interrogation
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
大体时间：1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter

Change in 12-Item Short Form Health Survey (SF-12) questionnaire score / The SF-12 questionnaire is a validated health-related quality of life instrument with two subscales: Physical Component Summary (PCS) and Mental Component Summary (MCS). Each subscale ranges from 0 to 100 points, where higher scores indicate better health-related quality of life.
1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
Electrical performance of the device
大体时间：Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter

Pacing thresholds (in Volts at 0.24 ms pulse width)
Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
Electrical performance of the device
大体时间：Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter

Sensing Amplitude (R-wave, in millivolts [mV])
Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
Electrical performance of the device
大体时间：Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter

Lead impedance (in Ohms [Ω])
Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
Electrical performance of the device
大体时间：Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter

Estimated battery longevity (in years)
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
大体时间：1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter

in %
1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
Left ventricular dimensions on Echocardiography
大体时间：1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter

end-diastolic and end-systolic diameters, in mm
1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
Right ventricular function on Echocardiography
大体时间：1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter

Tricuspid Annular Plane Systolic Excursion (TAPSE) in mm
1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Karl Landsteiner University of Health Sciences

合作者

University Hospital St. Polten

调查人员

  • 首席研究员：Julia Mascherbauer, MD, Professor、Department of Internal Medicine III, University Hospital of St. Pölten

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年6月18日

初级完成 (估计的)

2035年1月1日

研究完成 (估计的)

2035年1月1日

研究注册日期

首次提交

2025年9月16日

首先提交符合 QC 标准的

2025年11月17日

首次发布 (实际的)

2025年11月24日

研究记录更新

最后更新发布 (实际的)

2026年11月5日

上次提交的符合 QC 标准的更新

2026年11月4日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • GS3-EK-4/899-2024

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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