Status:
NOT_YET_RECRUITING
Study on the Safety and Effectiveness of the SnowyTM PFO Closure System
Lead Sponsor:
Hangzhou Dinova EP Technology Co., Ltd
Conditions:
Patent Foramen Ovale
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
To evaluate the safety and effectiveness of the SnowyTM PFO closure system in plugging patent foramen ovale
Detailed Description
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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2027
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT05360771
Start Date
October 20 2023
End Date
December 20 2027
Last Update
June 7 2023
Active Locations (1)
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1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029