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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05360771
Other study ID # PFO-001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 20, 2023
Est. completion date December 20, 2027

Study information

Verified date June 2023
Source Hangzhou Dinova EP Technology Co., Ltd
Contact Kong Xiangqing, MD
Phone +8602563806360
Email xiangqing_kong@sina.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the safety and effectiveness of the SnowyTM PFO closure system in plugging patent foramen ovale


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 242
Est. completion date December 20, 2027
Est. primary completion date December 20, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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

Locations

Country Name City State
China The First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Hangzhou Dinova EP Technology Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The success rate of PFO effective occlusion The amount of right to left shunt (RLS) confirmed by imaging examination after occluder implantation is grade 0-I 6 months after the procedure
Secondary Number of Participants with Device success 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 immediately after the procedure
Secondary Number of Participants with Procedural success 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 immediately after the procedure
Secondary Complete closure rate No RLS is confirmed by imaging examination after occluder implantation 6 months after the procedure
Secondary Migraine Headache Impact Test (HIT-6) scores 6 months after operation (compared with baseline) The scores range from 36 to 78 (higher scores mean a worse outcome). 6 months after the procedure
Secondary Incidence of serious adverse events 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 5 years after the procedure
Secondary Incidence of device-related adverse events Adverse medical events related to the use of devices during clinical trials 5 years after the procedure
Secondary All-cause mortality during follow-up 5 years after the procedure
Secondary All-cause stroke during follow-up 5 years after the procedure
See also
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