To evaluate the safety and effectiveness of the SnowyTM PFO closure system in plugging patent foramen ovale
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
242
Percutaneously occlusion of PFO with SnowyTM PFO closure system
Percutaneously occlusion of PFO with Cardi-o-fix PFO occluder
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
The success rate of PFO effective occlusion
The amount of right to left shunt (RLS) confirmed by imaging examination after occluder implantation is grade 0-I
Time frame: 6 months after the procedure
Number of Participants with Device success
The successful implantation of occluder is defined as the successful delivery and release of occluder during operation, the position of occluder is appropriate and the morphological structure is normal
Time frame: immediately after the procedure
Number of Participants with Procedural success
The occluder is successfully implanted and there are no severe adverse events (SAE) during routine hospitalization. SAE include but are not limited to death, systemic embolism, occluder embolism/displacement, occluder thrombosis, heart injury and perforation, pericardial tamponade / pericardial effusion (pericardial effusion leads to hemodynamic damage or requires pericardiocentesis; prolonged hospitalization for more than 48 hours; hospitalization is required), infective endocarditis, atrial fibrillation, severe vascular access complications
Time frame: immediately after the procedure
Complete closure rate
No RLS is confirmed by imaging examination after occluder implantation
Time frame: 6 months after the procedure
Migraine Headache Impact Test (HIT-6) scores 6 months after operation (compared with baseline)
The scores range from 36 to 78 (higher scores mean a worse outcome).
Time frame: 6 months after the procedure
Incidence of serious adverse events
Events that cause death or serious deterioration of health conditions during clinical trials, including fatal diseases or injuries, permanent defects in body structure or function, and the need for medical or surgical intervention to avoid permanent defects in body structure or function
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Time frame: 5 years after the procedure
Incidence of device-related adverse events
Adverse medical events related to the use of devices during clinical trials
Time frame: 5 years after the procedure
All-cause mortality during follow-up
Time frame: 5 years after the procedure
All-cause stroke during follow-up
Time frame: 5 years after the procedure