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临床试验/NCT04477499
NCT04477499已完成不适用

Ablation of Ventricular Tachycardia Guided by Multi-site Pacing Using Parallel Mapping

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2020年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
Single procedure freedom from ventricular recurrence at 1 year

研究概览

简要总结

Catheter ablation in patients with ventricular tachycardia using a new mapping algorithm called, parallel mapping, that is aimed to increase the specificity of mapping and the outcome of ablation.

详细描述

In patients with scar in the hearts after heart attacks, the risk for dangerous abnormal heart rhythms, including sudden death is high. This is because dead muscle fibers are replaced by scar tissue, creating a physiological condition promoting abnormal heart rhythms.These abnormal heart rhythms are called ventricular arrhythmias or ventricular tachycardias. In these patients, ablation procedures can be helpful, however the recurrence rate of arrhythmias after ablation remains unacceptably high. The primary reason for this high recurrence rate is nonspecific mapping methodologies for identifying the heart area responsible for these arrhythmias. Therefore, new methods for increasing the specificity of mapping have been the subject of significant research for many years, however implementation of these methods in clinical practice has been challenged by limited technologies. Recently, a new mapping technology named "parallel mapping" has been developed, received FDA approval and is routinely utilized at the Cleveland Clinic. However, the workflow of using parallel mapping, and the efficacy of ablation using this technology have not been evaluated.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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
  • History of scar-mediated sustained ventricular tachycardia
  • Failure of therapy with Anti arrhythmic drugs
  • Implanted ICD or a plan for ICD implantation after the ablation
  • Willingness to adhere to the study restrictions and comply with all post procedural follow-up requirements
  • Ability to understand the requirements of the study and sign an informed consent

排除标准

  • Patients with reversible causes of ventricular tachycardia including ongoing ischemia or electrolyte abnormalities
  • Contraindication to anticoagulation therapy
  • Stroke within 30 days before enrollment
  • Life expectancy <1 year
  • Individual has a known, unresolved history of drug use or alcohol dependency lacks the ability to comprehend or follow instructions or would be unlikely or unable to comply with study follow-up requirements
  • Pregnant or breast feeding at time of signing consent
  • Patient undergoing cardiac transplantation
  • Enrolled or participates in other drug or device studies

结局指标

主要结局

Single procedure freedom from ventricular recurrence at 1 year

时间窗: 12 months

Number of VT

次要结局

  • Freedom from implantable cardioverter defibrillator (ICD) shocks(12 months)
  • Reduction in mapping time using parallel mapping algorithm(12 months)
  • Reduction in radiofrequency ablation time(12 months)

研究者

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

Jakub Sroubek

Principal Investigator

The Cleveland Clinic

研究点 (1)

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