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

Starting soon · Not applicable

Conditions studied: Patent Foramen Ovale (PFO)

In brief

A prospective, multicenter, randomized controlled, non-inferiority clinical trial to evaluate the efficacy and safety of the patent foramen ovale suture system in the closure treatment of patent foramen ovale. A parallel controlled comparison will be conducted using the Amplatzer PFO Occluder manufactured by Abbott Medical Devices (Shanghai) co., Ltd. as the control device, to evaluate the safety and efficacy of the Patent Foramen Ovale Suture System in the closure treatment of patent foramen ovale.

Key facts

Study ID

NCT07726927

Run by

Shenzhen Bihe Medical Co., Ltd

People needed

244

Starts

2026-06-30

Expected to finish

2032-07-31

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

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