Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Increase of tricuspid regurgitation by at least one grade (on a scale from 0-4)
研究概览
简要总结
Registry for patients undergoing pacemaker/ICD implantation including a transtricuspid lead with and without intraprocedural transesophageal echocardiography to evaluate risk factors for lead induced tricuspid regurgitation.
详细描述
Lead induced tricuspid regurgitation is a common finding after pacemaker/ICD Implantation. Transesophageal echocardiography (TEE) might be used to guide lead implantations in order to prevent tricuspid regurgitation.
In this registry, patients undergoing pacemaker/ICD implantation including a transtricuspid lead are enrolled. While in most patients lead implantation is guided by fluroscopy, in some patients lead implantation is guided by TEE in addition to fluroscopy.
Aims of this registry: Evaluation of
- Incidence of lead induced tricuspid regurgitation
- Mortality and morbidity of lead induced tricuspid regurgitation
- Identification of risk factors for lead induced tricuspid regurgitation
- Influence of the lead position within the tricuspid valve on the incidence of lead induced tricuspid regurgitation
- Prevention of lead induced tricuspid regurgitation by TEE-guided lead implantation
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •indication for pacemaker/ICD implantation including a transtricuspid lead according to guidelines
排除标准
- •pre-existing RV lead
- •pre-existing TR >2
结局指标
主要结局
Increase of tricuspid regurgitation by at least one grade (on a scale from 0-4)
时间窗: 2 - 7 days post-implant (at hospital discharge)
Lead induced tricuspid regurgitation measured by transthoracic echocardiography
次要结局
- Lead revisions(30 days)
- Dose-are product(Intraprocedural)
- Increase of tricuspid regurgitation by at least one grade (on a scale from 0-4)(12 months)
研究者
Daniel Braun, MD
Attending Physician
LMU Klinikum