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

Patent Foramen Ovale Clinical Trial

Official title:

A Prospective, Multicenter, Randomized Controlled Clinical Study on the Safety and Effectiveness of the SnowyTM PFO Closure System in Plugging Patent Foramen Ovale

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05360771
• Other study ID #: PFO-001
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• Patent Foramen Ovale

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