NCT05360771

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 242 (estimated)
• Sponsor: Hangzhou Dinova EP Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Patent Foramen Ovale

Interventions

Type	Name	Description
DEVICE	SnowyTM PFO closure system	Percutaneously occlusion of PFO with SnowyTM PFO closure system
DEVICE	Cardi-o-fix PFO occluder	Percutaneously occlusion of PFO with Cardi-o-fix PFO occluder

Timeline

• Start date: 2023-10-20
• Primary completion: 2023-12-20
• Completion: 2027-12-20
• First posted: 2022-05-04
• Last updated: 2023-06-07

Locations

1 site across 1 country: China