Activation Pattern and Acute Hemodynamics of His and Left Bundle Pacing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Improvement in myocardiac activation
研究概览
简要总结
Background Cardiac Resynchronization Therapy (CRT) is proven to improve survival and heart function of patient with certain electrical conduction abnormality and heart failure. However, in patient with certain electrical conduction abnormality, being nonresponder is observed in up to 40% in patient receiving CRT. Conventionally the surgical approach of CRT is to implant one pacing lead in the right heart and one in the left heart to resynchronize the contraction and the pacing lead in the left heart is usually placed in the posterior or lateral portion of the left heart. However, this single approach may not be optimal, especially for those patients with conduction abnormality known to have no response to CRT. Purpose of the clinical investigation The purpose of the Activation Pattern and Acute Hemodynamics of His and Left Bundle Pacing is to study the acute effect on the heart function and conduction abnormality of His and left bundle pacing in conventional CRT candidate. During CRT implantation, Hisbundle lead and Left bundle pacing lead will be placed and the acute effect on heart function will be studied by a wire placed in the left ventricle of the heart and the activation pattern will be studied by a noninvasive global mapping system. The pacing approach that optimally corrects conduction abnormality and improvement on the heart function acutely will be determined
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adult (aged 18 or above) of both sexes
- •Candidate for CRT therapy according to international guidelines.7
- •Informed consent by the patient
- •Already received stable dose of guideline directed medical therapy for at least 3 months
排除标准
- •Participating in another study
研究组 & 干预措施
Tailor-made CRT delivery
Cardiac resynchronization therapy given according to Electrical Activation Mapping result
干预措施: Electrical Activation Mapping Guided Cardiac resynchronization therapy (Device)
结局指标
主要结局
Improvement in myocardiac activation
时间窗: 6 months
Correction of activation abnormality as evaluated by global noninvasive mapping system (ECGi) seen as an increase in acute dp/dt \> 5% from baseline with left bundle pacing comparing to biventricular pacing.
次要结局
- Implantation success rate(during procedure)
- Echocardiogram parameters: degree of mitral regurgitation(6 months)
- Change in New York Heart Association class(6 months)
- Cine images and chest X ray(6 months)
- Echocardiogram parameters: strain imaging(6 months)
- Echocardiogram parameters: left ventricular systolic and diastolic volume(6 months)
- Procedure duration(during procedure)
- Device parameter: lead impedance(6 months)
- Echocardiogram parameters: left ventricular ejection fraction(6 months)
- post-operative complication rate(6 months)
- Device parameter: defibrillation sensitivity(6 months)
- Change in 6 minute hall walk test result(6 months)
- Device parameter: defibrillation threshold(6 months)
- Change in HF Patient Global Assessment Questionnaire outcome(6 months)
研究者
Professor Bryan Ping Yen YAN
Professor
Chinese University of Hong Kong