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临床试验/NCT01182389
NCT01182389已完成不适用

A Prospective Randomised Study of Early Robotic Ablation by Substrate Elimination of Ventricular Tachycardia

Imperial College London6 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2011年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
6
主要终点
Any appropriate ICD therapy

研究概览

简要总结

Ventricular tachycardia (VT) is an abnormal rapid heartbeat which occurs after a heart attack and can cause sudden death. Patients at risk of this rhythm disturbance usually receive an implantable cardioverter defibrillator (ICD) that can prevent death by returning the heart's rhythm back to normal by electrically stimulating the heart but in doing so gives the patient painful and debilitating shocks. The first ICD shock after implantation appears to be a powerful predictor of subsequent shock therapy as well as being a predictor of of increased mortality in patients with primary prevention ICDs. In patients who receive repeated shocks VT ablation is performed to 'burn' the abnormal area of the heart that causes the problem. However, it is often only performed as a last resort as it is technically challenging. We believe that performing VT ablation using the robotic system early after the first episode of VT after ICD implantation, may reduce the number of painful shocks received by the patient and possibly increase life expectancy and quality of life.

200 patients from 5 european countries will be recruited in a prospective, open, randomised trial. Eligible, consenting patients who have experienced their first episode of VT since ICD implantation, will be randomised in a 1:1 manner into treatment arms of either VT ablation or standard 'conventional' therapy and followed-up every 4 months over two years to assess the number of subsequent ICD shocks, hospitalisation, mortality and quality of life.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males or females eighteen (18) to eighty-five (85) years old
  • ICD implantation for post-infarct primary or secondary prophylaxis
  • First episode of VT detected (within monitor zone or therapy (ATP /shock delivered) or by 12 lead ECG if the rate below the detection level of the device.
  • Suitable candidate for catheter ablation
  • Signed informed consent

排除标准

  • Contraindication to catheter ablation
  • Ventricular tachycardia due to transient, reversible causes
  • Presence of a left ventricular thrombus
  • Severe cerebrovascular disease
  • Active gastrointestinal bleeding
  • Renal failure (on dialysis or at risk of requiring dialysis)
  • Active infection or fever
  • Life expectancy shorter than the duration of the trial
  • Allergy to contrast
  • Intractable heart failure (NYHA Class IV)
  • Bleeding or clotting disorders or inability to receive heparin
  • Serum [K+] <3.5 or >5.0mmol/L
  • Serum Creatinine >200umol/L
  • Uncontrolled diabetes (HbA1c ≥73mmol/mol or HbA1c ≤64mmol/mol and Fasting Blood Glucose ≥9.2mmol/L)
  • Malignancy needing therapy
  • Pregnancy or women of child-bearing potential not using a highly effective method of contraception
  • Unable to give informed consent
  • Unable to attend follow-up in ICD clinics

研究组 & 干预措施

robotic VT Ablation

Active Comparator

Robotic VT ablation by substrate elimination

干预措施: Robotic VT Ablation (Procedure)

Conventional therapy

Active Comparator

review of ICD programming to ensure that detection and therapy will occur appropriately.

干预措施: Conventional Therapy (Other)

结局指标

主要结局

Any appropriate ICD therapy

时间窗: 24 months post randomisation

次要结局

  • Mortality(24 months post randomisation)
  • Treatment Failures defined as either2 ICD shocks or 5 ATP episodes(24 months post randomisation)
  • Total therapy rate(24 months post randomisation)
  • All cause hospitalisation(24 months post randomisation)
  • Quality of Life(12 months post randomisation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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