Optimization of Response to Cardiac Resynchronization Therapy by Electrocardiogram: an Assessment of Medium-term Response
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Clinical response
研究概览
简要总结
New simpler methods to optimize cardiac resynchronization therapy (CRT) are being evaluated, such as the use of the electrocardiogram.
In this prospective, double-blind, study, the investigators will evaluate:
Primary endpoint: To compare the clinical response to CRT in patients with the programming optimized by QRS versus the nominal suggested by the device.
Secondary endpoints:
- To compare cardiac remodeling in patients with the programming optimized by QRS versus the nominal suggested by the device.
- To evaluate the degree of asynchrony in both groups (nominal versus optimization by QRS) with respect to the intrinsic rhythm.
- To evaluate the echocardiographic improvement in left ventricular (LV) filling in both groups.
- To evaluate the differences in the optimal atrioventricular (AV) delay with atrial sensing or atrial pacing.
For that, 180 patients with an indication for CRT will be randomized to nominal programming of the device or optimization by the electrocardiogram for a narrower QRS. A clinical and echocardiographic evaluation will be done at baseline, 6 and 12 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with standard indication of cardiac resynchronization
- •Ejection fraction ≤35%.
- •QRS duration ≥120 ms.
- •New York Heart Association Functional Class 2-4..
- •Left ventricular diameter ≥55 mm.
- •Optimal medical treatment.
排除标准
- •Patient refusal.
- •Cardiopathy with a reversible cause.
- •Prevision of heart transplantation.
- •Atrial fibrillation.
- •Complete AV block.
- •AV delay >250 ms.
- •Right bundle branch block.
- •Severe peripheral vascular disease.
- •Other diseases with < 1 year life expectancy
研究组 & 干预措施
Nominal
CRT device is programmed with the nominal values.
干预措施: Device programming: nominal (Other)
Narrow QRS
CRT device is programmed by QRS optimization
干预措施: Programming optimization by QRS (Other)
结局指标
主要结局
Clinical response
时间窗: 12 months
Clinical response: survival without heart transplantation or death and \>10% increased distance in the 6MWT.
次要结局
- Echocardiographic response(12 months)
- Pacing/sensing AV delay difference(12 months)
研究者
Elena Arbelo
Coordinator of the AF programme
Hospital Clinic of Barcelona