跳至主要内容
临床试验/NCT05636046
NCT05636046招募中不适用

Transseptal Catheterization Registry. An Italian Overview

Luigi Sacco University Hospital10 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2022年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
10
主要终点
Accomplishment of transseptal catheterization and electrophysiology procedure requiring transseptal catheterization

研究概览

简要总结

The goal of this observational study is to learn about the changing over the time of transseptal (TSP) catheterization for catheter ablation of arrhythmias in the left heart. This study aims to investigate if auxiliary tools for TSP catheterization improved the safety and efficacy.

详细描述

Data regarding transseptal catheterization in the Centers involved will be retrospectively collected over the past 10 years.

Will be collected:

  1. patients characteristics
  1. type of procedure requiring transseptal catheterization
  2. success rate
  3. adverse events
  4. use of tools for transseptal catheterization:
  • intracardiac echocardiography (ICE) guidance
  • simplified transseptal puncture
  • "pig tail" catheter
  • "safe sept" guidewire
  • powered radiofrequency transseptal needle

研究设计

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

入排标准

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

入选标准

  • •patients underwent transseptal catheterization of left side heart interventional procedures (catheter ablation)

排除标准

  • •patients with learning disabilities

结局指标

主要结局

Accomplishment of transseptal catheterization and electrophysiology procedure requiring transseptal catheterization

时间窗: Procedure time

accomplishment fo transseptal catheterization

Adverse events related to inadvertent puncture cardiac structures other than atrial septum

时间窗: Procedure time

absence of adverse events related to transseptal catheterization

次要结局

未报告次要终点

研究者

发起方
Luigi Sacco University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gianfranco Mitacchione

Principal Investigator - Cardiac Electrophysiologist

Luigi Sacco University Hospital

研究点 (10)

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