Electrical Resynchronization and Acute Hemodynamic Effects of Direct His Bundle Pacing Compared to Biventricular Pacing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Left ventricular activation time
研究概览
简要总结
The aims are to compare Direct His Bundle Pacing (DHBP) with biventricular pacing (BiV) in terms of electrical resynchronization using electrocardiographic imaging (ECGI) and also in terms of acute hemodynamical effect using finger plethysmography and conduction velocimetry. The study will be a randomized crossover design with acute measurements.
详细描述
By recruiting native conducting tissue to relay electrical activation of the ventricles via the Purkinje fibre network, DHBP may potentially achieve greater electrical resynchronization and hemodynamic benefit compared to BiV where the electrical activation wavefronts propagate from two discrete pacing sites. Electrical synchrony achieved by these pacing modes have however never been compared. Furthermore, the acute hemodynamic effect of DHBP has been compared to BiV only in a small single study to date. The aims are to compare DHBP with BiV in terms of electrical resynchronization using electrocardiographic imaging (ECGI) and also in terms of acute hemodynamical effect using finger plethysmography and conduction velocimetry. The primary endpoint will be left ventricular activation time, with secondary endpoints including various electrical (right ventricular activation time, total ventricular activation time etc) and hemodynamic parameters (systolic pressure, cardiac output, cardiac contractility). It is expected that DHBP offers shorter left ventricular activation time (i.e. better synchrony) and hemodynamic benefit compared to BiV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Treatment of heart failure with a standard indication for CRT (NYHA III-IV, LVEF < 35% and QRS > 130ms; or LVEF< 40% and requirement for frequent ventricular pacing, irrespective of baseline QRS duration) and optimal medical treatment.
- •Permanent atrial fibrillation (allowing connection of the DHBP lead to the atrial port).
- •Patients implanted with 1) a CRT pacemaker or CRT defibrillator 2) a His lead with selective or non-selective DHBP, connected to the atrial port of the generator 3) a functional right ventricular lead and 4) a functional coronary sinus lead.
- •DHBP with selective or non-selective His capture
排除标准
- •Age <18 years
- •Pregnancy
- •Inability to undergo CT or an MRI (e.g. due to severe claustrophobia)
- •Inability or refusal to sign the patient informed consent form.
研究组 & 干预措施
Direct His Bundle Pacing
Pacing from the His bundle lead
干预措施: Pacing (Device)
Biventricular Pacing
Pacing from the right ventricular and coronary sinus leads
干预措施: Pacing (Device)
结局指标
主要结局
Left ventricular activation time
时间窗: 5 minutes
Duration of left ventricular electrical activation
次要结局
- Right ventricular activation time(5 minutes)
- Cardiac output(5 minutes)
- Systolic pressure(5 minutes)
- Total ventricular activation time(5 minutes)
- Cardiac contractility(5 minutes)
研究者
Haran Burri, MD
Professor
University Hospital, Geneva