Cardiac Resynchronisation Therapy In Patients With Narrow QRS Morphology And Heart Failure: Mechanistic Insights From Cardiac MRI And Electroanatomical Mapping
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- LV dP/dT during 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). Also CRT has been seen to improve some heart failure patients with a normal electrical conduction (seen on the ECG as a narrow QRS complex). The investigators aim to see if cardiac MRI can be used to select patients with normal electrical conduction for CRT, therefore expanding the number of people who would stand to benefit from this treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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.
- •NYHA grade III-IV heart failure
- •LVEF<35%
- •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.
- •Contraindication to an MRI scan
- •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
研究组 & 干预措施
Mechanical Dyssynchrony
Those with cardiac MRI evidence of mechanical dyssynchrony
干预措施: Temporary pacing study (Procedure)
Mechanical Dyssynchrony
Those with cardiac MRI evidence of mechanical dyssynchrony
干预措施: Body Surface Mapping (Radiation)
No Mechanical Dyssynchrony
Those without mechanical dyssynchrony on cardiac MRI
干预措施: Temporary pacing study (Procedure)
No Mechanical Dyssynchrony
Those without mechanical dyssynchrony on cardiac MRI
干预措施: Body Surface Mapping (Radiation)
结局指标
主要结局
LV dP/dT during pacing
时间窗: during temporary pacing study, approximately 2 hours
To assess LV dP/dT during different pacing modalities by intraventricular pressure wire. A dP/dT change of \>10% from baseline is a positive result.
次要结局
- Correlation of electrical and mechanical dyssynchrony(Data is collected prior to temporary pacing study, the post processing needed in order to correlate this data may take up to 2 months)