NCT03992560招募中不适用
A Prospective Randomised Multi-centre Trial Comparing cArdiac MRI Guided CRT Versus Conventional CRT Implantation in Patients With Ischaemic Cardiomyopathy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 218
- 试验地点
- 2
- 主要终点
- >15% reduction in end systolic volume
研究概览
简要总结
The purpose of the study is to determine whether MRI guided CRT implantation (using Siemen's software prototype) is superior to standard treatment in terms of CRT response. Data will be collected at enrolment, implant, pre-discharge, 6 weeks and 6 months. The total duration of the investigation will be 6 months.
The primary endpoint will be assessed by calculating the difference in the proportion of responders (>15% reduction in end systolic volume derived from 2-dimensional transthoracic echocardiogram at 6 months post CRT 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
- Single (Care Provider)
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
- •>18yrs of age
- •Standard indication for CRT-P or CRT-D according to European Society of Cardiology (ESC)/European Heart Rhythm (EHRA) guidelines.1
- •Stable on optimal medical therapy for at least 3 months
- •Ischaemic aetiology
- •Patients with atrial fibrillation can be included
排除标准
- •Any contraindication to pacing /implantable cardioverter-defibrillator (ICD) implant
- •Requirement for endocardial pacing
- •Contraindication to gadolinium contrast enhanced cardiac Magnetic Resonance (MR) scanning
- •Significant claustrophobia
- •Significant renal impairment with estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2
- •Existing pacemaker or ICD system or extraction of a CRT system within the last 6 months
- •Participation in other studies with active treatment/ investigational arm
- •Pregnant or planning to become pregnant in the next 7 months
结局指标
主要结局
>15% reduction in end systolic volume
时间窗: 6 months
\>15% reduction in end systolic volume derived from 2-dimensional transthoracic echocardiogram at 6 months post CRT implant
次要结局
- >10% reduction in end diastolic volume(6 months)
- 5% absolute increase in left ventricular ejection fraction(6 months)
研究者
研究点 (2)
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