Study on the Safety and Effectiveness of the SnowyTM PFO Closure System
NCT ID: NCT05360771
Last Updated: 2023-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
242 participants
INTERVENTIONAL
2023-10-20
2027-12-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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treatment group
Percutaneously occlusion of PFO with SnowyTM PFO closure system
SnowyTM PFO closure system
Percutaneously occlusion of PFO with SnowyTM PFO closure system
control group
Percutaneously occlusion of PFO with Cardi-o-fix PFO occluder
Cardi-o-fix PFO occluder
Percutaneously occlusion of PFO with Cardi-o-fix PFO occluder
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
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Hangzhou Dinova EP Technology Co., Ltd
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Kong Xiangqing, MD
Role: primary
Other Identifiers
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PFO-001
Identifier Type: -
Identifier Source: org_study_id
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