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临床试验/NCT01429753
NCT01429753Unknown2 期

A Prospective Randomised Study of Advanced Imaging Guided Cardiac Resynchronisation Therapy (CRT) vs Conventional CRT Implantation in Patients With Chronic Heart Failure

Guy's and St Thomas' NHS Foundation Trust0 个研究点目标入组 270 人开始时间: 2011年10月最近更新:
适应症

试验速览

阶段
2 期
入组人数
270
主要终点
Change in the proportion of CRT responders

研究概览

简要总结

Cardiac resynchronisation therapy (CRT) is an established treatment for improving symptoms in patients with congestive heart failure (CHF) by left ventricular (LV) pacing. CRT can help to improve LV function in patients with heart failure if those regions of the myocardium which are most compromised by electromechanical dyssynchrony can be identified and effectively stimulated. There still remains, however, a significant rate of up to 30% of patients who do not respond to treatment. Reasons for lack of benefit can be related to the inability of identifying and effectively stimulating those regions of myocardium, which are most compromised by electromechanical dyssynchrony. The investigators hypothesize that by using cardiac MR and 3D echo to identify scar, reconstruct coronary sinus anatomy, and determine the site of latest LV activation, the investigators can find the best place to implant the left ventricular lead. By avoiding scar and pacing in the site of latest activation, the investigators believe the investigators will reduce dyssynchrony and thus improve overall heart function. The researchers thus aim to increase the proportion of people who respond to treatment. The researchers also believe that the procedure may be streamlined so as to reduce procedure duration, radiation dose and dose of iodinated contrast medium.

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
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

入选标准

  • >18yrs of age
  • Standard indication for CRT=P or CRT=D according to NICE criteria (Clinical symptoms of heart failure despite medical therapy, broad QRS >120ms and significant LV dysfunction LEF <35%)
  • Stable on optimal medical therapy for at least 3 months
  • No exclusion to pacing /ICD
  • Ischaemic or non-ischaemic aetiology

排除标准

  • Any contraindication to pacing /ICD implant
  • Contraindication to MR scanning
  • Claustrophobia
  • Significant renal impairment (estimated GFR <30)

结局指标

主要结局

Change in the proportion of CRT responders

时间窗: 6 months

次要结局

  • Change in echo derived end systolic (ESV) and diastolic volumes(6 months)
  • Six month assessment of change in 6 minute walk distance and VO2 max (CPEX)(6 months)
  • Procedural success(0 months)
  • Procedure duration(0 months)
  • Radiation dose(0 months)
  • Contrast dose(0 months)
  • Procedural complications(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Manav Sohal

Clinical Research Fellow

Guy's and St Thomas' NHS Foundation Trust

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