Impact of Partial Capsule Decortication on Device-related Infection in Patients Receiving Cardiac Implantable Electronic Device Replacement: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,016
- 试验地点
- 1
- 主要终点
- Rate of major CIED-related infection
研究概览
简要总结
Increasing number of cardiac implantable electronic devices (CIEDs) have been implanted in the worldwide every year, which is accompanied by the growing number of CIED-related infection, especially in patients with CIED replacement. This multicenter, prospective, single-blinded, randomized controlled trial is to confirm the impact of partial capsule decortication on device-related infection in patients receiving CIED replacement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient is at least 18 years of age
- •Patient is planned to undergo at least one of the following procedures:
- •a) Patient has existing CIED (pacemaker, or CRT-P, or ICD, or CRT-D) and is undergoing pulse generator replacement or upgrade with a new generator. b) Patients planned to have leads added, or extracted and added for upgrades.
- •Patient is willing to sign and date informed consent
排除标准
- •History of CIED-related infection
- •Open the pocket for any reason within the last one year
- •Any evidence indicating active infection
- •Requirement of long term vascular access for any reason
- •Expected survival time is less than one year
- •Patients who were pregnant or breastfeeding
- •Participation in another study that may confound the results of this study
- •Patient is unable to comply with scheduled follow up
结局指标
主要结局
Rate of major CIED-related infection
时间窗: Within the first year after the operation
Infections that resulted in CIED system removal, an invasive CIED procedure (e.g., pocket revision without removal), treatment with long-term antibiotic therapy (if the patient was not a candidate for system removal) with infection recurrence after discontinuation of antibiotic therapy, or death.
次要结局
- Rate of device dysfunction(Within the first year after the operation)
- All-cause mortality(Within the first year after the operation)
- Rate of all CIED-related infection(Within the first year after the operation)
- Rate of minor CIED-related infection(Within the first year after the operation)
- Rate of pocket hematoma(Within the first year after the operation)