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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Patent Foramen Ovale
• Intervention / Treatment: Device: SnowyTM PFO closure system; Device: Cardi-o-fix PFO occluder

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.

• Study Type: Interventional
• Enrollment (Estimated): 242
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kong Xiangqing, MD; Phone Number: +8602563806360; Email: xiangqing_kong@sina.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • The First Affiliated Hospital of Nanjing Medical University
      • Contact: Kong Xiangqing, MD
      • Sub-Investigator: Peng Xiaoping, MD
      • Sub-Investigator: Cheng Ziying, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment group; Percutaneously occlusion of PFO with SnowyTM PFO closure system	Device: SnowyTM PFO closure system; Percutaneously occlusion of PFO with SnowyTM PFO closure system
Experimental: control group; Percutaneously occlusion of PFO with Cardi-o-fix PFO occluder	Device: Cardi-o-fix PFO occluder; Percutaneously occlusion of PFO with Cardi-o-fix PFO occluder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Complete closure rate	No RLS is confirmed by imaging examination after occluder implantation	6 months after the procedure
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
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
Incidence of device-related adverse events	Adverse medical events related to the use of devices during clinical trials	5 years after the procedure
All-cause mortality during follow-up		5 years after the procedure
All-cause stroke during follow-up		5 years after the procedure

Collaborators and Investigators

• Sponsor: Hangzhou Dinova EP Technology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): October 20, 2023
• Primary Completion (Estimated): December 20, 2023
• Study Completion (Estimated): December 20, 2027

Study Registration Dates

• First Submitted: April 23, 2022
• First Submitted That Met QC Criteria: April 29, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects, Atrial; Heart Septal Defects; Foramen Ovale, Patent
• Other Study ID Numbers: PFO-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No