Prospective, Investigational Study to Assess the Safety and Performance of LeadExx LC System in Lead Extraction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 主要终点
- Adverse events
研究概览
简要总结
The study's main purpose is to evaluate the safety and performance of the LeadExx LC System and its ability to safely extract leads.
The study will enroll 10 patients scheduled for CIED lead extraction. The decision upon lead extraction will be based upon the applicable Heart Rhythm Society guidelines or European Heart Rhythm Association (EHRA).
详细描述
The use of implantable cardiac devices has been exponentially increasing, and lead extraction has become a necessary procedure. But lead extraction has potentially serious complications, including venous or myocardial tear, cardiac tamponade, and even death. Powered sheaths, such as Excimer laser or a radiofrequency system, have been used for extraction of ICD or pacemaker leads. However, the Heart Rhythm Society (HRS) has stated that "possible predictors of major complications were implant duration of the oldest lead, female gender, ICD lead removal, and use of the laser extraction technique, multiple leads, and calcified leads".
To reduce the risk of the lead extraction procedure and therefore reduce the number of abandoned leads, LeadExx had developed its system.
The LC system is an active disposable system provided sterile for single use. The system is comprised of the following two main parts:
a. Dilation Unit (DU) - (invasive, sterile) b. Control Unit- (CU) - (non-invasive, sterile fluid path) The physical connection between the units is achieved by 3 Luer locks that connect the CU Solenoids' output to 3 flexible tubes at the proximal end of the DU.
- Dilation Unit (DU):
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18-75 years old.
- •Scheduled for an CIED lead extraction upon current guidelines
- •Willing and able to sign the informed consent.
- •Lead implant duration more than 1 year and less than 5 years.
- •Patient with Lead size 7F
- •Number of implanted leads 1-3
排除标准
- •Lead implant duration is less than 1 year or more than 5 years.
- •Patients with acute and chronic lead infections
- •Pericardial or subcutaneous CIED systems (without trans venous CIED lead)
- •Pregnant or lactating.
- •Patients with expected survival of less than 1 year.
- •Subjects who are participating in another clinical study.
- •Subjects who are unable or unwilling to follow the study schedule of visits.
- •Contraindication to administration of iodinated contrast (creatinine > 2.0 or contrast allergy)
- •Patients with a history of venous thromboembolism, coagulopathy or malignancy.
结局指标
主要结局
Adverse events
时间窗: 1 month
Monitoring Adverse events that are related to the extraction procedure, or the extraction system
次要结局
- Performance(During procedure)
- Practical removal of intact lead(During procedure)