NCT04322877Unknown不适用
Cardiac Resynchronisation Therapy In Patients With Heart Failure: Mechanistic Insights From Cardiac MRI And Electroanatomical Mapping
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Improvement in LV dP/dTmax >10 percent during temporary multisite pacing
研究概览
简要总结
Cardiac Resynchronisation Therapy (CRT) is a specialist pacemaker procedure that aims to improve the efficiency of the heartbeat. This treatment is used routinely in patients with heart failure and a delay in electrical conduction across the heart seen on the surface ECG (heart tracing). The investigators aim to assess acute response to CRT and compare different methods of delivering CRT using hemodynamic data from invasive dP/dTmax and electroanatomical data from either invasive mapping or non-invasive body surface mapping.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or Female, aged 18 years or above.
- •Either 1) has CRT system in situ or 2) has a planned CRT system implant or 3) has a planned upgrade to CRT from a standard pacemaker
- •NYHA grade II-IV heart failure
- •LVEF<35%
- •Intrinsic QRS duration >120ms
- •On optimum medical therapy for heart failure
- •Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
- •Able (in the Investigators opinion) and willing to comply with all study requirements.
- •Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
排除标准
- •Female participants who is pregnant, lactating or planning pregnancy during the course of the study.
- •Scheduled elective surgery or other procedures requiring general anaesthesia during the study.
- •Participant who is terminally ill or is inappropriate for placebo medication
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- •Rate uncontrolled atrial fibrillation precluding a cMR
- •Significant peripheral vascular disease precluding an EP study
- •A contraindication to anticoagulation
- •A prosthetic aortic or tricuspid valve
- •Significant Aortic valve disease
- •Known LV thrombus
- •Insufficient capacity to consent to the study
结局指标
主要结局
Improvement in LV dP/dTmax >10 percent during temporary multisite pacing
时间窗: Intra-procedure
次要结局
- Electrical dyssynchrony measured from electro-anatomical mapping(Intra-procedure)
研究者
研究点 (2)
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