Safety and Efficacy of the Patent Foramen Ovale Suture System for the Closure of Patent Foramen Ovale

The investigational device of this trial, the patent foramen ovale suture system, is a new product for PFO closure treatment, and some study sites have no prior experience with PFO suture procedures. Therefore, 1 to 2 roll-in subjects will be enrolled at sites without relevant suture experience. Subjects in the roll-in phase will not be included in the statistical analysis of the confirmatory trial.The confirmatory clinical trial adopts a prospective, multicenter, randomized controlled and non-inferiority design to evaluate the efficacy and safety of the patent foramen ovale suture system in the closure treatment of patent foramen ovale. After patients enrolled in this study sign the informed consent form, those who meet all inclusion criteria and do not meet any exclusion criteria will be randomly assigned to the experimental group and the control group at a ratio of 1:1. Subjects in the experimental group will receive PFO closure treatment with the PFO suture system developed by Shenzhen Bihe Medical Co., Ltd., while those in the control group will be treated with the Amplatzer PFO Occluder manufactured by Abbott Medical Devices (Shanghai) Co., Ltd. Follow-up visits will be conducted for treated subjects before discharge or at 7 days post-operation, as well as at 30 days, 90 days, 180 days, 360 days post-operation, and 2 to 5 years after surgery.

Inclusion criteria

• The subject is aged between 18 and 65 years old;
• Patent foramen ovale (PFO) confirmed by imaging examination with moderate or greater right-to-left shunt (RLS) (both condition a and b shall be satisfied simultaneously):a) Patent foramen ovale (PFO) confirmed by echocardiography (TTE or TEE);b) Moderate or greater right-to-left shunt confirmed by contrast echocardiography (cTTE, cTEE or cTCD);
• Diagnosed as PFO-related stroke/TIA after clinical exclusion of other etiologies;
• The subject or legal guardian understands the trial purpose, voluntarily participates in the trial, signs the written informed consent form, and is willing to complete follow-up in accordance with the protocol requirements.

Exclusion criteria

• Carotid atherosclerotic stenosis (stenosis degree >50% confirmed by ultrasound or CTA);
• Large cerebral infarction within 4 weeks (defined by imaging as hypodense area on CT involving more than 1/2 of the MCA perfusion territory, or infarct volume>145 ml on diffusion-weighted imaging (DWI));
• Intracardiac thrombus or tumor, intracardiac vegetation;
• Acute myocardial infarction or unstable angina within 6 months;
• Presence of left ventricular aneurysm or left ventricular wall motion abnormality;
• Severe valvular heart disease, such as severe mitral regurgitation or stenosis, severe aortic regurgitation or stenosis, mitral or aortic valve vegetation;
• Combined cardiomyopathy (including hypertrophic cardiomyopathy, restrictive cardiomyopathy, dilated cardiomyopathy, etc.);
• Severe heart failure with LVEF <35%;
• Pulmonary hypertension (mPAP >25 mmHg);
• Right-to-left shunt caused by other etiologies, including atrial septal defect or pulmonary arteriovenous fistula;
• Concomitant atrial fibrillation or atrial flutter;
• Active endocarditis or other untreated infections;
• Thrombosis in the access vessel or conditions interfering with the normal deployment of the study device;
• Hepatic and renal dysfunction (alanine transaminase (ALT) or aspartate transaminase (AST) >3 times the upper limit of normal, or serum creatinine (Cr) >2 times the upper limit of normal);
• Coagulopathy or contraindications to antiplatelet or anticoagulant therapy;
• Pregnant or lactating females, or those planning pregnancy during the trial period;
• The investigator judges that the PFO anatomy is unsuitable for occluder implantation or suture repair with the suture system, or has contraindications to PFO occlusion/suture treatment;
• Malignant tumor or other diseases with life expectancy less than 1 year;
• Participation in another clinical trial with trial endpoints not yet reached;
• Other conditions deemed inappropriate for enrollment in this trial by the investigator.