Predictors of Tricuspid Regurgitation Progression and Adverse Outcomes in Different Pacing Modes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Tricuspid regurgitation progression（Progression of tricuspid regurgitation ≥ grade 0.5）
研究概览
简要总结
Tricuspid regurgitation (TR) is a common complication following cardiac implantable electronic device (CIED) implantation, with severe TR being associated with increased rates of heart failure hospitalization and all-cause mortality, significantly impairing patients' quality of life. With technological advancements, physiological pacing modalities have demonstrated superior clinical efficacy and safety profiles compared to conventional pacing methods.
This study aims to evaluate predictors of adverse outcomes and TR progression in CIED recipients under different pacing modalities, thereby providing clinical guidance for high-risk patients.
详细描述
This retrospective study analyzed patients undergoing pacemaker implantation from January 2015 to March 2025, stratified by pacing modality (right ventricular/conduction system/biventricular pacing) and TR progression (worsened [≥1-grade increase] vs non-worsened TR).
The protocol included: (1) 3D echocardiographic assessment of TR mechanisms, (2) quantitative fluoroscopic analysis of lead parameters (tension, mobility, angulation), (3) multivariable regression evaluating pacing modes and TR progression on clinical outcomes, and (4) documentation of device-related complications (lead dislodgement/infection) and heart failure rehospitalization.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Adult patients
- •Patients with an implantable electronic heart device (CIEDs)
- •The patient underwent pacemaker implantation at Qianfoshan Hospital between 2015 and 2025
排除标准
- •Patients with severe tricuspid regurgitation or those who have undergone tricuspid valve surgery or interventional treatment prior to pacemaker implantation
- •Patients with severe valvular heart disease, congenital heart disease, or arrhythmias
- •Patients with single-chamber pacemakers or poor images
结局指标
主要结局
Tricuspid regurgitation progression（Progression of tricuspid regurgitation ≥ grade 0.5）
时间窗: Mean follow-up of 1 year
Grading of tricuspid regurgitation severity:Grade 0: None Grade 0.5: Trace Grade 1: Mild Grade 1.5: Mild to moderate Grade 2: Moderate Grade 2.5: Moderate to severe Grade 3: Severe
次要结局
- Heart Failure Readmission Rate After CIED Implantation(Mean follow-up of 1 year)
研究者
Haiyan Wang
Director
Qianfoshan Hospital