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临床试验/NCT05775783
NCT05775783已完成不适用

Effectiveness, Complications, and Mortality of Transvenous Lead Extraction in Patients With and Without Infections-Prospective Registry From a High-volume Center.

Medical University of Silesia1 个研究点 分布在 1 个国家目标入组 702 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
702
试验地点
1
主要终点
Minor complications

研究概览

简要总结

The number of devices for cardiac pacing and defibrillation has increased in recent years. However, although they have improved in terms of quality and extended lifespan after implantation, they are not free from complications. The Achilles' heel of cardiac implantable electronic devices (CIEDs) is the risk of infections and lead failure, which, when untreated, can be the cause of poor outcomes and a high mortality rate. Abandoned leads predict serious adverse events, such as lead infections, death, electrical interference, or potential problems during future TLE procedures. Therefore, it is crucial to extract them, presuming the decision is warranted based on a patient's individual risk. TLE is a standard treatment for device-related complications, and while TLE procedures are relatively rare in comparison to the number of CIEDs that are implanted, the need for TLE has grown in recent years due to the aging population, an increasing number of upgrades of pacing systems, and a related rise in infection rates. According to the European Lead Extraction ConTRolled Registry (ELECTRa), the most frequent indication for TLE is CIED infection, with the majority of them being local infections. The second most common reason for TLE is lead dysfunction, which is observed in 38.1% of cases. In such cases, the treatment must be fast and effective. TLE is the first-line treatment for those patients and prevents further serious or even lethal complications. However, the goal of TLEis often to remove leads and also maintain access in the occluded vein by moving the sheath over the lead to the lead myocardial interface. TLE technology has recently shown substantial progress in improving the safety and effectiveness of the procedure. As a rule, single traction is the primary method of treatment, followed by more aggressive techniques such as locking stylet, mechanical sheaths, powered extraction sheaths, and femoral snares.

Data obtained in previous studies. indicated that identifying predictors of such undesirable adverse events appeared essential for optimizing the procedural technique. Another vital element to address were patients deemed at high risk of stricter follow-up and stronger secondary prevention strategies; notably, infected TLE patients have unique characteristics. The analysis of independent predictor outcomes could, thus, allow clinicians to better identify high-risk TLE patients. In light of this, the current registry aimed to investigate the composite short-term outcomes for infected and non-infected patients in real-world populations.

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
是

入选标准

  • •Consecutive patients who underwent TLE between 2016 and 2025 entered the EXTRACT Registry.

排除标准

  • 未提供

结局指标

主要结局

Minor complications

时间窗: 30 days

Complications that did not require surgical intervention or involved minor surgical interventions that did not affect the patient's functionality.

All-cause death or occurrence of any major complication

时间窗: 30 days

Procedural success

时间窗: 30 days

Removing all targeted leads and their component parts without causing any permanently disabling complication or procedure-related death.

Clinical success

时间窗: 30 days

Removing all targeted leads and their component parts from the cardiovascular system or leaving a small part of the lead (\<4cm) that did not adversely affect the objectives of the procedure or cause procedural-related death

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

Kszysztof Gołba

Prof.

Medical University of Silesia

研究点 (1)

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