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临床试验/NCT03847025
NCT03847025招募中不适用

The Oregon Health & Science University Cardiac Implantable Electronic Device Extraction Registry

Oregon Health and Science University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
safety (acute complications, per HRS consensus document)

研究概览

简要总结

Implanted cardiac devices are commonly used to treat a wide variety of heart diseases, including arrhythmias, cardiac resynchronization in select heart failure patients, and life threatening heart rhythms. Approximately 400,000 devices are implanted annually, and more than 3 million patients currently have implanted devices1.

Implanted cardiac devices are made to 2 components, the can and the leads. The can contains the electric circuits and the battery, which must be replaced every 5-10 years. The can is connected to external leads which pass through the subclavian vein, and depending on the device, into the vena cava, right atrium, right ventricle, and/or coronary sinus. Leads typically last longer than the battery, and are simply reconnected to a new can at the time of replacement.

Certain clinical situations necessitate lead removal, including pocket infection, device related endocarditis, venous stenosis or occlusion with the need for new access, and removal of abandoned or malfunctioning leads. Removing the leads is technically difficult due to fibrosis, and requires specialized equipment. Compared to lead implantation, extraction of leads is relatively rare, with a life time risk of a device patient needing an extraction in the 1-5% range. Given that this is a relatively rare procedure and is only done at a few centers, documentation of our experiences with lead extraction can lead to ongoing improvements in both procedural techniques and outcomes.

详细描述

Study Procedures

This is a retrospective review of data on patient characteristics (such as age, gender, co-morbidities), procedure specifications and indications, and outcomes of lead extraction done at OHSU.

Patients who have undergone either pacemaker or defibrillator lead extraction will have their charts reviewed for the desired data, which will then be compiled into a database. All procedures will be part of routine clinical care.

Data Analysis:

This is an observational registry study; there are no primary or secondary outcomes. Data will be analyzed to determine patient and procedural characteristics, procedure indications, complications and outcomes

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Undergoing lead extraction

排除标准

  • registry--n/a

结局指标

主要结局

safety (acute complications, per HRS consensus document)

时间窗: duration of hospitalization, typically 2 days to 2 weeks

Primary outcome is safety of the lead extraction procedure, in terms of acute complications, per HRS consensus document.

次要结局

未报告次要终点

研究者

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

Charles Henrikson, MD

Associate Professor of Medicine

Oregon Health and Science University

研究点 (1)

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