Empiric Versus Imaging Guided Left Ventricular Lead Placement in Cardiac Resynchronization Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 2
- 主要终点
- Number of participants with clinical response to CRT
研究概览
简要总结
The aim of this study is to investigate if imaging guided optimal left ventricular (LV) lead placement improves the response rate to cardiac resynchronization therapy (CRT). Consecutive patients meeting the standard criteria for CRT are included in a prospective, double-blinded, randomized trial to LV lead positioning either 1) guided by cardiac imaging using echocardiography, single-photon emission computed tomography, and visualization of cardiac venous anatomy (cardiac computed tomography (CT), venography) to target an epicardial vein at the site of latest mechanical activation without scar tissue or 2) using standard LV lead placement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic heart failure (New York Heart Association functional class II - IV) despite stabile optimal medical therapy.
- •ECG with QRS ≥ 120 milliseconds and left bundle branch block (LBBB) or paced QRS ≥ 180 milliseconds.
- •LV systolic dysfunction (Ejection Fraction ≤ 35%).
- •written informed consent.
排除标准
- •Expected lifetime < 6 months.
- •Recent myocardial infarction (< 3 months).
- •Pregnant or lactating.
- •Inadequate echocardiographic images for determination of site with latest mechanical activation
- •No written informed consent.
结局指标
主要结局
Number of participants with clinical response to CRT
时间窗: 6 months after CRT implantation
Response to CRT defined as a combination of survival, free of hospitalization for heart failure, and improved functional status. The primary endpoint is attained if the patient is registered for one of the following three events: 1. Death from any cause. 2. Hospitalization for heart failure. 3. No improvement in New York Heart Association (NYHA) functional class and \<10% improvement in 6-minutes hall walk at end of study period.
次要结局
- All cause mortality(6 months after CRT implantation)
- Hospitalization for heart failure(6 months after CRT implantation)
- Changes in NYHA functional class(6 months after CRT implantation)
- Changes in 6-Minutes Hall Walk(6 months after CRT implantation)
- Changes in Quality of Life(6 months after CRT implantation)
- Changes in Biochemical marker of heart failure(6 months after CRT implantation)
- Changes in LV Ejection Fraction(6 months after CRT implantation)
- Changes of LV end-diastolic volume(6 months after CRT implantation)
- Changes of LV end-systolic volume(6 months after CRT implantation)
- Changes of LV dyssynchrony(6 months after CRT implantation)
- Changes of mitral regurgitation grade(6 months after CRT implantation)
- Duration of CRT implantation(During CRT implantation)
- Complications(6 months after CRT implantation)