Mechanical and Electrical Dyssynchrony During His-Bundle Pacing (Selective and Non-selective) Versus His-Bundle Area Right Ventricular Pacing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Free-wall-LV-to-RV-delay
研究概览
简要总结
The aim of this study is to evaluate mechanical and electrical cardiac dyssynchrony in patients with pacemakers and the right ventricular electrode implanted in His Bundle area.
详细描述
Permanent His Bundle Pacing (HBP) is a well-known method of cardiac pacing which is increasingly used in everyday practice. After lead implantation in His Bundle area (HBA) capture of various tissues can be achieved: A. right ventricular myocardium near to HBP; B. cardiac conduction system selectively or nonselectively (with concomitant regional myocardium activation). The different excitability and refractory periods decide which tissue, myocardium or/and the conduction system is effectively paced. A lot of clinical trials revealed the advantage of HBP over apical ventricular pacing (AVP). HBP improves clinical (NYHA, quality of life, hospitalization rate) and echocardiographic (left ventricular dimension and ejection fraction) indicators of heart failure.
We are going to compare mechanical and electrical synchrony during the various type of myocardium activation: HBP (nsHBP or sHBP), RV pacing near HBA and native heart rhythm (if possible) in each patient recruited to the study. Adequate pacemaker programming will allow achieving different activations as shown above. The mechanical synchrony will be estimated by transthoracic echocardiography and the electrical one by the detailed analysis of ECG.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all adult patients after implantation of pacemaker system with pacing lead successfully captured His Bundle (selectively or/and nonselectively)
排除标准
- •not willing or incapable to give written informed consent;
- •previous implanted cardiac electronic device (pacemaker, implantable cardioverter-defibrillator, cardiac resynchronization therapy device)
结局指标
主要结局
Free-wall-LV-to-RV-delay
时间窗: Long term: 12-15 months after pacemaker implantation
InterVentricular Mechanical Dyssynchrony Parameter 2
systolic dyssynchrony index
时间窗: Mid-term: 3-6 months after pacemaker implantation
Ventricular Mechanical Dyssynchrony Parameter 1
Septal-to-posterior wall motion delay
时间窗: Long term: 12-15 months after pacemaker implantation
IntraVentricular Mechanical Dyssynchrony Parameter 1
Opposing wall motion delay
时间窗: Mid-term: 3-6 months after pacemaker implantation
IntraVentricular Mechanical Dyssynchrony Parameter 2
QRS duration
时间窗: Long term: 12-15 months after pacemaker implantation
Electrical dyssynchrony Parameter
Interventricular mechanical delay
时间窗: Long term: 12-15 months after pacemaker implantation
InterVentricular Mechanical Dyssynchrony Parameter 1
次要结局
- Radial strain(Long term: 12-15 months after pacemaker implantation)
- Global longitudinal strain(Long term: 12-15 months after pacemaker implantation)
- Left Ventricular Ejection Fraction(Long term: 12-15 months after pacemaker implantation)
- Left ventricular output track velocity-time integral(Long term: 12-15 months after pacemaker implantation)
- Diastolic Filling Time(Long term: 12-15 months after pacemaker implantation)
