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临床试验/NCT04208997
NCT04208997终止3 期

Continuation of Antiarrhythmics Following caThEteR Ablation for Ventricular Tachycardia (AFTER-VT) Trial: A Pilot Randomized Clinical Trial

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2019年12月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
终止
入组人数
5
试验地点
1
主要终点
Number of Participants Dead or With VT Recurrence at One Year

研究概览

简要总结

The investigators aim to study if patients that undergo catheter ablation for ventricular tachycardia benefit from continuation of Vaughan-Williams class III antiarrhythmic drugs for 3 months after their ablation.

详细描述

Catheter ablation is a valuable option to control recurrent Ventricular Tachycardia (VT) in patients with structural heart disease. A recent trial proved that catheter ablation is superior to escalation of anti arrhythmic drugs (AADs) in prevention of VT recurrence and death (Sapp et al. N Engl J Med 2016; 375:111-121). However, even with ablation, approximately 20-50% of patients will have an episode of VT within one year. This is probably explained in part by the substrate (myocardial scar from cardiomyopathy) persists after VT ablation and that ablation lesions heal and evolve over days, weeks and even months. Most patients (if not all) of patients who undergo ablation are on AADs and usually have failed at least one of them. Furthermore, most AADs, and Vaughan Williams class III AADs in particular (the most frequently used to treat VT) carry significant and life-threatening side effects from pulmonary, hepatic and hematologic toxicities up to significant ventricular arrhythmias and death. Since these patients have already failed AADs, and the significant adverse profile of AADs, there is no evidence that the benefits of continuation of these drugs will surpass the risks after ablation. Therefore the investigators decided to ask the question:

Among patients with structural heart disease who undergo VT ablation, does continuation of class III AADs for 3 months, increases VT-free survival compared to discontinuation of antiarrhythmic drug therapy?

Based on expert consensus about clinical equipoise in regards of AAD continuation after VT ablation, the investigators decided to select patients with lowest risk of VT recurrence after ablation as our study population. The investigators aim to include in our study only those patients who have an Implantable Cardioverter-Defibrillator (ICD), who have NO inducible VT at the end of the ablation procedure and also who have NO inducible VT prior to discharge on a procedure called non-invasive programmed stimulation (NIPS). It has been shown that patients with inducible VT at the end of ablation and during NIPS have significantly higher risk of VT recurrence compared to those in whom VT was not induced. In NIPS, one uses the previously Implanted ICD to pace the ventricle fast enough to try to induce VT. Both procedures will be performed as usual practice in patients who undergo VT ablation in the arrhythmia service.

The specific aim of this pilot study is to evaluate whether the strategy of continuation of class III AADs following initial catheter ablation for VT, improves VT-free survival and reduces readmissions.

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

  • Age >18 years.
  • Able to give written, informed consent
  • Structural heart disease.
  • Implanted and normally functioning ICD or undergoing ICD implant at index admission.
  • Undergoing initial radiofrequency ablation procedure for sustained monomorphic VT.
  • Receiving a class III AADs prior to VT ablation.
  • No VT inducible at the end of VT ablation.
  • No VT inducible on non-invasive programmed stimulation following VT ablation.

排除标准

  • LV assist device in place
  • Decompensated heart failure and/or requiring continuous inotropic therapy and/or awaiting cardiac transplantation
  • Ongoing acute coronary syndrome.
  • Mechanical prosthetic aortic and mitral valves.
  • Pedunculated or mobile left ventricular thrombus.
  • Persistent VT at the end of index catheter ablation.
  • Absolute contraindications for class III AADs.
  • Participation in other trial.
  • VT induced on NIPS after VT ablation.
  • Another reason for continuation of class III AADs (i.e., atrial fibrillation).

研究组 & 干预措施

Continuation of antiarrhythmic drugs

Experimental

Patients will continue the class III antiarrhythmic drug they were receiving prior the VT catheter ablation for 3 months after the ablation.

干预措施: Antiarrhythmic drug (Drug)

结局指标

主要结局

Number of Participants Dead or With VT Recurrence at One Year

时间窗: One year after ablation

A composite of all-cause mortality and VT recurrence one year after index VT ablation

次要结局

  • Number of Participants With VT/Electrical Storm(One year after ablation)
  • Number of Participants With Readmission for Heart Failure(One year after ablation)
  • All-cause Mortality(One year after ablation)
  • Number of Participants With VT Recurrence(One year after ablation)

研究者

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

Arvindh Kanagasundram

Assistant Professor of Medicine

Vanderbilt University Medical Center

研究点 (1)

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