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临床试验/NCT04697797
NCT04697797招募中不适用

Mechanical and Electrical Dyssynchrony During His-Bundle Pacing (Selective and Non-selective) Versus His-Bundle Area Right Ventricular Pacing

Medical University of Lodz1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年12月14日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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