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临床试验/NCT06692218
NCT06692218招募中不适用

Leadless Pacemaker Implantation Positions and Its Relationship with Procedure Efficacy and Complication

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 196 人开始时间: 2024年8月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
196
试验地点
1
主要终点
Location of leadless pacemaker implantation

研究概览

简要总结

Leadless pacemakers (LP) are safe and effective alternatives to transvenous pacemakers in select patients. Advances in battery and electronics technology allow for the entire pacemaker system to be implanted into the right ventricle, bypassing many of the weaknesses of transvenous pacemakers. Traditionally leadless pacemakers have been implanted in the right ventricular (RV) septum to prevent cardiac perforation, and much emphasis is placed during implantation to ensure a septal implant. However, in Asians with smaller heart sizes, septal implantation may be unfeasible. Cases of RV free wall implant have been achieved without any complications. This study aims to examine patients previously implanted with LP and determine their final attachment location. If a substantial portion of complication-free patients had RV free wall implants, then it can be argued the additional effort to ensure a septal implant is unnecessary. Additionally, intraoperative data, such as the intracardiac electrogram, may contain parameters correlated with implant position. This study also aims to study this correlation to guide future implant procedures.

This is a prospective-retrospective cohort study. Patients who will implant leadless pacemakers or already implanted leadless pacemakers since 1 Jan 2015 will be recruited. After the implantation, patients will be invited back for a noncontrast ECG-gated CT heart. It will be timed at the end diastole and a 3D reconstruction will be performed. The attachment of the leadless pacemaker to the RV will be adjudicated from the CT. The patients' pre-operative laboratory tests, baseline demographics, medical history, LP electrical data and pre- and post-operative medication regiment will be collected retrospectively from their medical records in the Hospital Authority's Clinical Management System (CMS) and Clinical Data Analysis and Reporting System (CDARS).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who will implant leadless pacemaker or already implanted leadless pacemaker since 1 Jan 2015
  • Patients with ability to provide informed consent

排除标准

  • Patients who cannot provide informed consent
  • Patient < 18 years old
  • Pregnant patients

结局指标

主要结局

Location of leadless pacemaker implantation

时间窗: From date of enrollment to date of CT or echocardiogram, up to 1 year

Determine the exact location of leadless pacemaker implantation

次要结局

  • Implant location prediction with electrical parameters(From date of enrollment to date of CT or echocardiogram, up to 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tam Tsz Kin

Assistant Professor

Chinese University of Hong Kong

研究点 (1)

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