Left Ventricular Pacing to Prevent Iatrogenic Tricuspid Regurgitation Caused by Conventional Right Ventricular Pacing: a Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Development of moderate or worse TR post implantation
研究概览
简要总结
Background and Aims Pacemaker implantation for treating bradyarrhythmias typically involves placing a pacing lead through the tricuspid valve (TV) into the right ventricular (RV) apex. It is now known that tricuspid regurgitation (TR) frequently results from this and may lead to increased morbidity or mortality. Recently, left ventricular (LV) pacing through an epicardial vein via the coronary sinus has been widely practiced due to the advent of biventricular pacing. This lead does not cross the TV, potentially reducing the risk of TV dysfunction and may also reduce the risk of LV dysfunction. The investigators hypothesize that LV pacing will prevent the onset of new TR or worsening of pre-existing TR in patients undergoing pacemaker implantation.
Methods Patients receiving a pacemaker for sick sinus syndrome (n=20) with an LV ejection fraction <40% will be randomly allocated to receive either conventional RV pacing or LV pacing via the coronary sinus. Serial 2D and 3D transthoracic echocardiography will be performed before implantation, one day post implantation, then at 1 week, 1 month, 6 months and 1 year. The primary endpoints will be new onset TR and the diagnosis of at least moderate TR. Other endpoints include biventricular function, ventricular dyssynchrony, complications of device implantation, mortality and major cardiovascular events.
详细描述
We hypothesize that left ventricular pacing via a coronary sinus approach can reduce the incidence of significant tricuspid regurgitation after pacemaker implantation in patients with normal left ventricular function.
The aim of this study is to compare the degree of tricuspid regurgitation caused by pacemaker implantation between the conventional techniques of implanting a ventricular lead implanted in the right ventricular apex versus implanting a ventricular lead in a left ventricular epicardial vein via a coronary sinus approach.
The secondary objective of our study is to evaluate whether left ventricular pacing is also less likely to cause ventricular dyssynchrony and dysfunction than right ventricular apical pacing.
This study is a single centre randomised clinical pilot study comparing 2 different lead implantation techniques to be assessed using both imaging techniques and follow up for clinical outcomes.
(i) Proposed study interventions The procedures in both arms of the study will be identical except for where the ventricular lead is placed. All parts of these procedures, including all the implanting equipment and pacing leads are standard routine clinical practice. The left ventricular leads used in this study are routinely used for pacing the left ventricle in patients receiving biventricular pacemakers or defibrillators for heart failure.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing dual chamber permanent pacemaker implantation for sick sinus syndrome. This is defined as symptomatic sinus node dysfunction manifest as sinus pauses or excessive sinus bradycardia and is diagnosed on continuous ECG monitoring or ambulatory ECG recording (Holter study).
- •Aged ≥21 years and able to give informed consent. The age limit is so that all patients are able to give informed consent personally.
排除标准
- •Left ventricular ejection fraction <40%.
- •Mobitz Type 2 second degree atrioventricular block, 2:1 atrioventricular block, high degree atrioventricular block or complete heart block.
- •Life expectancy less than 1 year due to medical co-morbidities.
- •Previous mechanical prosthetic tricuspid valve replacement, precluding the implantation of a right ventricular apical lead.
- •Tricuspid regurgitation that is at least moderate in severity.
- •Complex congenital heart disease precluding the placement of either a right ventricular apical lead or left ventricular lead via the coronary sinus
- •Vascular or coronary sinus anatomy unfavourable to either conventional RV lead or left ventricular lead implantation as confirmed on a coronary sinus venography at the time of implantation.
研究组 & 干预措施
LV pacing
Left ventricular pacing lead implanted via coronary sinus
干预措施: LV pacing (Device)
RV pacing
Conventional right ventricular pacing lead.
干预措施: RV pacing (Device)
结局指标
主要结局
Development of moderate or worse TR post implantation
时间窗: 6 months
At least moderate of worsening of tricuspid regurgitation at 6 months post implantation on echocardiography
次要结局
- Lead performance parameters(6 months)
- Major cardiovascular events(6 months)
- All cause mortality(6 months)
- Biomarkers of heart failure(6 months)
- Biventricular ventricular function and dyssynchrony(6 months)
- Procedural complications and device related complications(6 months)