SnowyTM PFO closure system: Percutaneously occlusion of PFO with SnowyTM PFO closure system
Cardi-o-fix PFO occluder: Percutaneously occlusion of PFO with Cardi-o-fix PFO occluder
Study summary
To evaluate the safety and effectiveness of the SnowyTM PFO closure system in plugging patent foramen ovale
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age: 18 to 65 years old, regardless of gender
2. Transthoracic echocardiographic contrast echocardiography (cTTE) confirmed the presence of PFO and at least moderate (see above definition) RLS (in Valsalva active/resting state)
3. Existence of at least one of the following conditions: 1) Unexplained stroke or TIA 2) intractable or chronic migraine
4. 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:
1. Patients have definite causes of stroke unrelated to the PFO
2. RLS caused by other causes, such as atrial septal defect or pulmonary arteriovenous shunt
3. Atrial fibrillation or atrial flutter
4. Mitral and aortic stenosis or severe regurgitation
5. Dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy
6. Active endocarditis or other untreated infectious diseases
7. Left ventricular ejection fraction (LVEF) \< 40%, or NYHA cardiac function grade III-IV
8. Uncontrollable hypertension
9. Previous intracardiac surgery
10. Myocardial infarction or unstable angina pectoris within 6 months
11. Contraindications to anticoagulants or antiplatelet drugs
12. High risk of bleeding
13. severe liver function impairment(alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal value)
14. Serum creatinine greater than 2 times the upper limit of normal or with any history of renal dialysis or renal transplantation
15. Severe pulmonary disease including pulmonary hypertension (clinical diagnosis)
16. Nickel or contrast allergy
17. Active or planned (within 12 months) pregnancy, or lactating female patients
18. Malignant tumors or other serious diseases resulting in a life expectancy of less than 12 months
19. Psychiatric conditions that may interfere with medical compliance and compliance with follow-up
20. Concomitant participation in other clinical trials
21. The investigator determines that the patient is unsuitable because of reasons not listed but thought to interfere with safe trial participation
Primary outcome measure(s)
The success rate of PFO effective occlusion — 6 months after the procedure The amount of right to left shunt (RLS) confirmed by imaging examination after occluder implantation is grade 0-I
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Nanjing Medical University
Nanjing
Jiangsu
More Hangzhou Dinova EP Technology Co., Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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