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Study on the Safety and Effectiveness of the SnowyTM PFO Closure System

Patent Foramen Ovale Clinical Trial

Official title:
A Prospective, Multicenter, Randomized Controlled Clinical Study on the Safety and Effectiveness of the SnowyTM PFO Closure System in Plugging Patent Foramen Ovale

Clinical Trial Summary

To evaluate the safety and effectiveness of the SnowyTM PFO closure system in plugging patent foramen ovale

Clinical Trial Description

A prospective, multicenter, randomized controlled clinical trial is conducted to evaluate the safety and effectiveness of PFO closure system produced by Hangzhou Dinova EP Technology Co., Ltd.., Ltd. in closing patent foramen ovale (PFO). 242 patients are expected to be selected. They are randomly divided into the PFO closure system treatment group (121 cases) and the Chinese medicine Shengjie Cardi-o-fix PFO occluder treatment group (121 cases) according to 1:1. All patients will be followed up to 7 days after operation or before discharge, 1 month, 3 month, 6 month, 1 year, 2 year, 3 year, 4 year and 5 year. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05360771
Study type Interventional
Source Hangzhou Dinova EP Technology Co., Ltd
Contact Kong Xiangqing, MD
Phone +8602563806360
Email xiangqing_kong@sina.com
Status Not yet recruiting
Phase N/A
Start date October 20, 2023
Completion date December 20, 2027
View Details
See also
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