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临床试验/NCT03645577
NCT03645577已完成不适用

Phrenic Nerve Injury During Pulmonary Vein Isolation With the Second-generation Cryoballoon: Clinical, Procedural, and Anatomical Characteristics

University of Luebeck1 个研究点 分布在 1 个国家目标入组 731 人开始时间: 2018年7月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
731
试验地点
1
主要终点
Incidence of phrenic nerve palsy

研究概览

简要总结

To determine the most frequent complication associated with cryoballoon PVI. The main hypothesis is to explore the incidence of phrenic nerve palsy.

研究设计

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

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 or older
  • Cryoballoon PVI
  • Periprocedural phrenic lesion

排除标准

  • 未提供

结局指标

主要结局

Incidence of phrenic nerve palsy

时间窗: 06/2012 until 04/2018

The overall incidence of phrenic nerve palsy during second and third Generation Cryoballoon based PVI will be evaluated.

次要结局

  • Predictors of phrenic nerve palsy(06/2012 until 04/2018)
  • Clinical course of phrenic nerve palsy(06/2012 until 04/2018)

研究者

发起方
University of Luebeck
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christian-H. Heeger, MD

PI

University of Luebeck

研究点 (1)

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