Patent Foramen Ovale
Conditions
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. 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.
Interventions
DEVICESnowyTM PFO closure system
Percutaneously occlusion of PFO with SnowyTM PFO closure system
DEVICECardi-o-fix PFO occluder
Percutaneously occlusion of PFO with Cardi-o-fix PFO occluder
Sponsors
Hangzhou Dinova EP Technology Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Procedural success | immediately after the procedure | 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 |
| Complete closure rate | 6 months after the procedure | No RLS is confirmed by imaging examination after occluder implantation |
| Migraine Headache Impact Test (HIT-6) scores 6 months after operation (compared with baseline) | 6 months after the procedure | The scores range from 36 to 78 (higher scores mean a worse outcome). |
| Number of Participants with Device success | immediately after the procedure | 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 |
| Incidence of device-related adverse events | 5 years after the procedure | Adverse medical events related to the use of devices during clinical trials |
| All-cause mortality during follow-up | 5 years after the procedure | — |
| All-cause stroke during follow-up | 5 years after the procedure | — |
| Incidence of serious adverse events | 5 years after the procedure | 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 |
Countries
China
Contacts
Primary ContactKong Xiangqing, MD
Outcome results
None listed