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

Launched by HANGZHOU DINOVA EP TECHNOLOGY CO., LTD · Apr 29, 2022

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ClinConnect Summary

The clinical trial is studying a device called the SnowyTM PFO Closure System, which is designed to help close a small hole in the heart known as a patent foramen ovale (PFO). This hole can sometimes be linked to unexplained strokes or severe migraines. The goal of the study is to determine how safe and effective this closure system is for patients with these conditions.

To participate in the trial, you need to be between 18 and 65 years old and have a confirmed PFO along with certain symptoms like a stroke or chronic migraines. If you join the study, you'll be informed about what to expect and will need to sign a consent form agreeing to participate and follow up with the research team. It’s important to note that some individuals may not qualify for the trial due to other health issues or conditions that could complicate their participation. If you think you might be eligible and are interested in finding out more, please discuss it with your healthcare provider.

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Eligibility criteria

• 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