Electrical Activation Mapping Guided Tailor Made Approach for Cardiac Resynchronization Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Responder rate of greater than 10% of LV end systolic volume reduction in patients undergoing tailor-made approach of CRT delivery at 6 months.
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, a good response is observed in less than 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 poor response to CRT.
Purpose of the clinical investigation
The purpose of the Electrical Activation Guided CRT Study is to study the effectiveness of a tailored made approach to CRT procedure by using a noninvasive globally mapping system studying the electrical conduction under different approaches to delivery CRT. The pacing approach that optimally corrects conduction abnormality will be determined before the actual implantation procedure.
Conduct of the Investigation
This study will include 93 patients with conduction abnormality that known to have a poor response to CRT from Prince of Wales Hospital, Hong Kong.Subjects will be followed up at 3 months and 6 months visit.
详细描述
The purpose is to prospectively study the feasibility to optimize configuration of CRT delivery for acute correction of electrical dyssynchrony using a noninvasive mapping of global electrical activation.
Study Hypothesis: Tailor-made configuration of CRT delivery is feasible and able to improve responder rate compare to single method of CRT delivery in candidates with known poor response to CRT.
Primary outcome measure: Responder rate of greater than 10% of LV end systolic volume reduction in patients undergoing tailor-made approach of CRT delivery at 6 months. The responder rate is to compare with pre-defined level of 40% for single method of CRT delivery namely biventricular pacing with LV lead in coronary sinus.
Sample Size: The total required sample size is 93 patients with device implanted.
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
- 是
入选标准
- •Adult (aged 18 or above) of both sexes
- •Ischemic or non-ischemic cause of heart failure
- •QRS duration > 120 ms, non -LBBB type of conduction disturbance
- •NYHA class III or above
- •Sinus rhythm
- •Informed consent by the patient
- •Already received stable dose of guideline directed medical therapy for at least 3 months
排除标准
- •LBBB* patients
- •Pregnant women
- •Participation in another study
- •Patient with contraindication to left ventricle catheterization by a retrograde aortic approach (eg mechanical aortic valve, severe aortic stenosis and aortic dissection) *The definitions of LBBB (QRS duration ≥130 ms; QS or rS in lead V1; broad R waves in leads I, aVL, V5, or V6; and absent q waves in leads I, V5, and V6).
结局指标
主要结局
Responder rate of greater than 10% of LV end systolic volume reduction in patients undergoing tailor-made approach of CRT delivery at 6 months.
时间窗: 6 months
Responder rate of greater than 10% of LV end systolic volume reduction measured by echocardiogram comparing baseline and 6 months post implant in patients undergoing tailor-made approach of CRT delivery. Responder rate of greater than 10% of LV end systolic volume reduction measured by echocardiogram comparing baseline and 6 months post implant in patients undergoing tailor-made approach of CRT delivery. The responder rate is to compare with pre-defined level of 40% for single method of CRT delivery namely biventricular pacing with LV lead in coronary sinus.
次要结局
- The hemodynamic responses of different methods of CRT delivery.(during procedure)
- Peri-operative and 6 months follow-up complications rate:(Peri-operative and 6 months)
- NYHA class(baseline and 6 months)
- Quality of life using Minnesota's questionnaire(baseline and 6 months)
- Electrical parameters including threshold, sensitivity and lead impedance of pacing leads at implant and 6 months follow-up.(during procedure and 6 months)
- Procedure duration of the optimal CRT delivery method(during procedure)
- The acute electrical dyssynchrony indices of different methods of CRT delivery.(during procedure)
- Implantation success rate of the optimal CRT delivery method(during procedure)
- Cine images (PA, LAO 300, RAO 300) and Chest X ray (PA view)(during procedure)
- Left ventricular systolic and diastolic volume at baseline and 6 months:(baseline and 6 months)
- Left ventricular ejection fraction at baseline and 6 months:(baseline and 6 months)
- 6 minute hall walk test(baseline and 6 months)
- Degree of mitral regurgitation at baseline and 6 months:(baseline and 6 months)
- Strain imaging at baseline and 6 months:(baseline and 6 months)
研究者
Professor Bryan Ping Yen YAN
Associate Professor
Chinese University of Hong Kong