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临床试验/JPRN-UMIN000047888
JPRN-UMIN000047888已完成未知

Transcatheter closure of secundum atrial septal defect using Cocoon Septal Occluder:- Immediate and long term results - Transcatheter closure of secundum atrial septal defect using Cocoon Septal Occluder:- Immediate and long term results

PS Institute of Cardiology Department of Cardiology0 个研究点目标入组 320 人开始时间: 2022年5月29日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
320

研究概览

简要总结

Efficacy 312(97.5%) Safety 312(97.5%) Mean Procedural time (mins) 23.5 Mean Fluoroscopy time (mins) 6.8 Periprocedural complications 27 (8.4%) Cardiac death 0 (0%) Device embolization 2 (0.6%) Cardiac perforation 1 (0.3%) Pericardial effusion 3 (0.9%) Transient supraventricular arrhythmias 15 (4.6%) Transient atrioventricular block 6 (1.8%) Local site hematoma 0 (0%) Stroke 0 (0%) Transient headache 8 (2.5%) Closure rate 312 (100%) Late embolization 0 (0%) Erosion 0(0%) Residual shunting 2 (0.6%)

研究设计

研究类型
Interventional

入排标准

年龄范围
4years-old 至 ot applicable(—)
性别
All

入选标准

  • 未提供

排除标准

  • Aanomalous pulmonary venous connection, Associated complex cardiac anomaly, Eisenmenger syndrome, Impaired left ventricular systolic function, and Inadequate (<4mm) inferior vena cava (IVC) rim

研究者

发起方
PS Institute of Cardiology Department of Cardiology

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