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临床试验/NCT03458273
NCT03458273Unknown不适用

Multi-center, Observational, Retrospective Comparison of the Feasibility, Safety, and Efficacy of Real Zero Fluoroscopy Versus Conventional Fluoroscopic Catheter Ablation With and Without 3D System Support: Propensity Matched Study

Medical University of Lublin3 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年3月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
3
主要终点
Procedural success rates

研究概览

简要总结

A Retrospective Propensity Matched Study comparing:

  • real zero fluoroscopy catheter ablation
  • conventional fluoroscopy catheter ablation without 3D system
  • conventional fluoroscopy catheter ablation with 3D system

详细描述

Catheter ablation is a well-established treatment to treat patients with a wide scope of heart arrhythmias.

The study is an investigator-initiated, retrospective analysis of prospectively collected data. The study population consists of patients with right-sided arrhythmias who underwent zero-fluoroscopy catheter ablation between the years 2016 and 2018 in 3 centers and a propensity score matched patients group of patients who:

  • underwent conventional fluoroscopy guided catheter ablation without 3D system (Ensite/Carto) support
  • underwent conventional fluoroscopy guided catheter ablation with 3D system (Ensite/Carto) support

Covariates for matching will be:

  • arrhythmia type
  • age of a patient
  • number of diagnostic catheters used during a procedure
  • type of a diagnostic catheter used during a procedure]

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • right atrial tachycardia
  • right atrial premature complexes
  • right atrial AVRT/WPW
  • right ventricle tachycardia / right ventricle premature complexes

排除标准

  • left atrium arrhythmia
  • left ventricle arrhythmia

结局指标

主要结局

Procedural success rates

时间窗: 3 months

arrhythmia recurrence within 3 months since the index procedure

次要结局

  • Fluoroscopy time(during procedure)
  • Acute procedural success(10-30 minutes)
  • Recurrence rate(6 months)
  • Total procedure time(during procedure)
  • Acute Complications rate(during procedure)
  • The length of stay during the hospitalization(1 month)
  • All Complications rate(6 months)

研究者

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

Maciej Wójcik, MD, PhD

Associate Professor

Medical University of Lublin

研究点 (3)

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