Prospective Study of Lead-associated Tricuspid Regurgitation in Patients Undergoing New Transvalvular Lead Insertion
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
- Worsening of TR of at least 1 grade
研究概览
简要总结
The goal of this clinical trial is to record the incidence of newly developed or worsening tricuspid valve regurgitation (TR) following the implantation of a pacemaker or defibrillator with a transvenous lead. To collect this data, a transthoracic echocardiogram (TTE) with 3D imaging of the tricuspid valve (TV) will be performed before and after pacemaker implantation, with particular emphasis on assessing the tricuspid valve. Additionally, routine follow-up visits will be conducted at 6 and 12 months post-intervention, during which a TTE, ECG, NT-proBNP measurement, and pacemaker check will be performed.
详细描述
The prevalence of tricuspid regurgitation (TR) in patients with a pacemaker or ICD/CRT device varies widely, ranging from 5% to 45% across different study protocols. To date, only retrospective analyses have shown that implantation of a device with a transvalvular lead can cause or worsen TR, highlighting the importance of early diagnosis. The aim of this study is to prospectively evaluate patients indicated for cardiac electronic device implantation to document the incidence of newly developed regurgitation (greater than trace) or worsening of existing regurgitation (by at least one grade). Additionally, the study will investigate predictive factors for the development or progression of TR.
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
- •medically indicated for pacemaker, ICD- or CRT implantation
- •No previous diagnosis of severe tricuspid regurgitation on enrollment
- •No existing transvalvular device (must be first implantation)
- •No other diagnosed severe valvular heart disease
- •Not previous diagnosis with pre-capillary pulmonary hypertension
- •No previous diagnosis of structural disease of the right ventricle (i.e. ACM, cardiac sarcoidosis, carcinoid...)
排除标准
- •Patients unable to give consent
- •Under the age of 18 years
- •Relevant pre-capillary pulmonary hypertension according to decision of the heart-team (sPAP echo >70 mmHg)
- •Severe tricuspid valve regurgitation (Grade 3 or worse) on enrollment
- •Patients who have undergone Lead-explantation
- •Exisiting valvular heart disease requiring treatment according to the decision of the heart-team. These patients may be enrolled in the study following treatment.
- •Previous tricuspid valve surgery
- •Patients with congenital heart disease (i.e. tetralogy of fallot, Ebstein's anomaly,...)
- •Pregnant or breastfeeding women
- •Life expectancy < 12 months
研究组 & 干预措施
Pacemaker-standard
Only pacemaker with standard positioning (no ICD leads, no LBBaP)
ICD
any ICD leads through tricuspid valve
LBBaP
Left bundle branch area pacing leads
结局指标
主要结局
Worsening of TR of at least 1 grade
时间窗: over the sutdy period up to 1 year after lead insertion
Worsening of tricuspid regurgitation of at least one grade from baseline before lead insertion through tricuspid valve
次要结局
- TR > mild at follow-up(during study time frame up to 1 year after Pacemaker/ICD implantation)
- NTproBNP change from baseline(at 6 and at 12 months after Pacemaker/ICD implantation)
- Hospitalization for heart failure (HFH)(up to 12 months after Pacemaker/ICD implantation)
研究者
Hazem Omran
Attending Physician
Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW