Clinical Impact of Cardiac Resynchronization Therapy on Heart Failure Patients With QuickOpt and Echo Optimization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Percent Change in Left Ventricular End Systolic Volume (LVESV) at 12 Months Compared to Baseline
研究概览
简要总结
The purpose of this study is to demonstrate that QuickOpt optimization can be as an alternative method for CRTP/D patients' optimization in clinical practice through the comparison of the improvement differences between the CRTP/D patients with different optimization at 12 months after implantation.The hypothesis is that the Heart Remolding parameter (LVESV) improvement of patients using QuickOpt parameters at 12 months after implant is not inferior (10%) to the patients by Echo optimization。
详细描述
Clinical studies have demonstrated that the AVTI from QuickOptTM related significantly to the max aorta VTI (AVTI) by Echo, the concordance correlation coefficient (CCC) was so high from 0.96 to 0.99.
But up to now, there are no clinical trials to evaluate mid-long term clinical outcome for CRTP/D patients by QuickOptTM and Echo optimization, this is indeed the main purpose of the study; in addition, the clinical impact, the status of arrhythmia and agents of all the enrolled patients, will be evaluated at 1 year after implant.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patient meets current CRT-P indications and be implanted with an SJM CRT-P device with V-V timing and a compatible lead system
- •Patient is able to provide written informed consent for study participation
排除标准
- •• Patient has limited intrinsic atrial activity (≤ 40 bpm)
- •Patient has persistent or permanent AF
- •Patient has a 2o or 3o heart block
- •Patient's life expectancy is <12 months
- •Patient is <18 years old
- •Patient is pregnant
- •Patient is on IV inotropic agents
- •Patients who are ongoing other devices or agents study
- •Patients with heart transplanted or waiting for heart transplant
- •Patients with Hypertrophic and obstructive cardiomyopathy
- •Patients with severe aortic valve and mitral valve stenosis or regurgitation without replacement
研究组 & 干预措施
Quickopt Group
the QuickOpt Group patients will be optimized by QuickOpt(IEGM);
干预措施: Cardiac Resynchronization Therapy (Device)
Echocardiography group
the Echo Group patients will be optimized by Echo.
干预措施: Optimization using echocardiography (Device)
结局指标
主要结局
Percent Change in Left Ventricular End Systolic Volume (LVESV) at 12 Months Compared to Baseline
时间窗: Baseline and12 months
The primary outcome is the percent change in LVESV at 12 months compared to baseline. This outcome measure is assessed through evaluation of echocardiograms at both baseline and 12 months, with a decrease in the percent change in LVESV at 12 months indicating clinical improvement. The percent change in patients with devices optimized with QuickOpt is compared with that of patients with devices optimized using standard echocardiography techniques to determine if one method of optimization results in a greater change in LVESV.
次要结局
未报告次要终点