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3D Transthoracic Echocardiographic Evaluation on Tricuspid Regurgitation Progression and Clinical Outcomes in Patients With Cardiac Implantable Electronic Device (3DECHO-TR)

2026年8月26日 更新者：Juwon Kim、Samsung Medical Center

The goal of this observational study is to learn about the development and worsening of tricuspid regurgitation (TR) in patients who have cardiac implantable electronic devices (CIEDs).

The main objective is to compare left bundle branch area pacing (LBBaP) and leadless pacemakers against conventional pacemakers in terms of TR exacerbation.

Participants with these devices will have their retrospective and prospective clinical data analyzed and will undergo 3D transthoracic echocardiography to identify the exact mechanical causes of TR.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

As the use of cardiac implantable electronic devices(CIED) increases, CIED-related tricuspid regurgitation (CIED-related TR) is emerging as a critical clinical issue. CIED-related TR is one of the most common causes of primary TR, with a reported incidence ranging from approximately 10% to 30%. Numerous studies have confirmed that the severity of CIED-related TR is closely associated with poor prognosis.

This condition is particularly noteworthy because, unlike secondary TR, it possesses mechanical causes that are potentially intervenable. However, most studies published to date have reported results based on 2D echocardiography, which often leads to ambiguity in identifying the exact mechanisms behind the exacerbation of tricuspid regurgitation. Furthermore, there is a significant lack of data regarding TR associated with more recently introduced procedures, such as left bundle branch area pacing (LBBaP) and leadless pacemakers. Therefore, this study aims to perform 3D transthoracic echocardiography on patients with lead-based CIEDs and leadless pacemakers to comparatively analyze LBBaP and leadless pacemaker patients against conventional pacemaker patients in terms of TR exacerbation. By combining retrospective and prospective clinical data, this research will analyze the incidence and clinical impact of these conditions.

研究类型

观察性的

注册 (估计的)

1000

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

学习地点

  • 韩国
    • Seoul
      • Seoul、Seoul、韩国、06351
        • 招聘中
        • Samsung Medical Center
        • 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

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Subjects aged 19 years or older who underwent de novo implantation of a leadless PPM or a cardiac implantable electronic device (PPM or ICD) with trans-tricuspid leads at Samsung Medical Center between 2022 and 2025, and are at least one year post-implantation

描述

Inclusion Criteria:

  • Aged 19 years or older.
  • Patients who are at least one year post-implantation of one of the following Cardiac Implantable Electronic Devices (CIEDs):

A. Permanent Pacemaker (PPM) B. Implantable Cardioverter-Defibrillator (ICD) C. Leadless Pacemaker

  • Patients who underwent the implantation procedure on or after January 2022.
  • Voluntary informed consent provided by the patient or their legal representative for the review of medical records and study-related data throughout the entire study period.

Exclusion Criteria:

  • Patients with lead-based CIEDs whose leads do not cross the tricuspid annulus or those with two or more leads crossing the annulus.
  • Patients whose baseline degree of tricuspid regurgitation (TR) cannot be assessed due to the absence of transthoracic echocardiography (TTE) performed within three months of the procedure.
  • Patients with a history of ventricular lead extraction.
  • Patients who have undergone tricuspid valve replacement surgery.
  • Individuals who refuse active medical treatment.

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

队列和干预

团体/队列
干预/治疗
A patient one year after receiving a cardiac implantable electronic device
Subjects aged 19 years or older who underwent de novo implantation of a leadless PPM or a cardiac implantable electronic device (PPM or ICD) at Samsung Medical Center between 2022 and 2025, and are at least one year post-implantation
诊断测试：3D Transthoracic echocardiographic evaluation
The incidence and mechanisms of worsening tricuspid regurgitation are identified through three-dimensional echocardiography, and the resulting structural and functional changes in the heart are evaluated.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
hospitalization due to heart failure
大体时间：From the date of CIED implantation until the date of the first heart failure hospitalization or the date of the study 3D transthoracic echocardiography, whichever occurred first, assessed up to 6 years.
From the date of CIED implantation until the date of the first heart failure hospitalization or the date of the study 3D transthoracic echocardiography, whichever occurred first, assessed up to 6 years.

次要结果测量

结果测量
大体时间
incidence of CIED related, associated TR
大体时间：Assessed at the time of the study 3D transthoracic echocardiography, performed at least 1 year after CIED implantation, up to 6 years after implantation.
Assessed at the time of the study 3D transthoracic echocardiography, performed at least 1 year after CIED implantation, up to 6 years after implantation.
re-admission due to any cause
大体时间：From the date of CIED implantation until the date of the first event or the date of the study 3D transthoracic echocardiography, whichever occurred first, assessed up to 6 years.
From the date of CIED implantation until the date of the first event or the date of the study 3D transthoracic echocardiography, whichever occurred first, assessed up to 6 years.
Tricuspid valve intervention
大体时间：From the date of CIED implantation until the date of the first event or the date of the study 3D transthoracic echocardiography, whichever occurred first, assessed up to 6 years.
From the date of CIED implantation until the date of the first event or the date of the study 3D transthoracic echocardiography, whichever occurred first, assessed up to 6 years.
transvenous lead extraction or reposition
大体时间：From the date of CIED implantation until the date of the first event or the date of the study 3D transthoracic echocardiography, whichever occurred first, assessed up to 6 years.
From the date of CIED implantation until the date of the first event or the date of the study 3D transthoracic echocardiography, whichever occurred first, assessed up to 6 years.

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

Samsung Medical Center

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)

2026年1月22日

初级完成 (估计的)

2028年1月31日

研究完成 (估计的)

2028年1月31日

研究注册日期

首次提交

2026年8月17日

首先提交符合 QC 标准的

2026年8月26日

首次发布 (实际的)

2026年8月31日

研究记录更新

最后更新发布 (实际的)

2026年8月31日

上次提交的符合 QC 标准的更新

2026年8月26日

最后验证

2026年1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

  • SMC 2026-01-010
  • KCT0011605 (其他标识符：Korea National Institute of Health)

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

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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