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

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

Detailed Description
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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.

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

Conditions
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Patent Foramen Ovale

Intervention / Treatment
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* Device: SnowyTM PFO closure system
* Device: Cardi-o-fix PFO occluder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 to 65 years old, regardless of gender Transthoracic echocardiographic contrast echocardiography (cTTE) confirmed the presence of PFO and at least moderate (see above definition) RLS (in Valsalva active/resting state) Existence of at least one of the following conditions： 1) Unexplained stroke or TIA 2) intractable or chronic migraine The subjects are informed of the nature of the study and agreed to all requirements for participation in the study, signed the informed consent form, and agree to complete the follow-up and follow-up examination Exclusion Criteria: Patients have definite causes of stroke unrelated to the PFO RLS caused by other causes, such as atrial septal defect or pulmonary arteriovenous shunt Atrial fibrillation or atrial flutter Mitral and aortic stenosis or severe regurgitation Dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy Active endocarditis or other untreated infectious diseases Left ventricular ejection fraction (LVEF) < 40%, or NYHA cardiac function grade III-IV Uncontrollable hypertension Previous intracardiac surgery Myocardial infarction or unstable angina pectoris within 6 months Contraindications to anticoagulants or antiplatelet drugs High risk of bleeding severe liver function impairment（alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal value） Serum creatinine greater than 2 times the upper limit of normal or with any history of renal dialysis or renal transplantation Severe pulmonary disease including pulmonary hypertension (clinical diagnosis) Nickel or contrast allergy Active or planned (within 12 months) pregnancy, or lactating female patients Malignant tumors or other serious diseases resulting in a life expectancy of less than 12 months Psychiatric conditions that may interfere with medical compliance and compliance with follow-up Concomitant participation in other clinical trials The investigator determines that the patient is unsuitable because of reasons not listed but thought to interfere with safe trial participation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>Percutaneously occlusion of PFO with SnowyTM PFO closure system | Device: SnowyTM PFO closure system<br>* Percutaneously occlusion of PFO with SnowyTM PFO closure system<br>|
| Experimental: control group<br>Percutaneously occlusion of PFO with Cardi-o-fix PFO occluder | Device: Cardi-o-fix PFO occluder<br>* Percutaneously occlusion of PFO with Cardi-o-fix PFO occluder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | immediately after the procedure | 
| Complete closure rate | No RLS is confirmed by imaging examination after occluder implantation | 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). | 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 | 5 years after the procedure | 
| Incidence of device-related adverse events | Adverse medical events related to the use of devices during clinical trials | 5 years after the procedure | 
| All-cause mortality during follow-up |  | 5 years after the procedure | 
| All-cause stroke during follow-up |  | 5 years after the procedure |