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.
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.
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;
Parallel
Patent Foramen Ovale Suture System
DeviceIn the experimental group, patients with patent foramen ovale (PFO) received PFO closure therapy using the Patent Foramen Ovale Suture System developed by Shenzhen Bihe Medical Co., Ltd.
Amplatzer PFO Occluder
DeviceIn the control group, patients with patent foramen ovale (PFO) received PFO closure therapy using the Amplatzer PFO Occluder developed by Abbott Medical Devices(Shanghai) Co., Ltd.
Successful occlusion rate at 360 days postoperatively
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Shenzhen Bihe Medical Co., Ltd
Lead sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborator
Fuwai Yunnan Cardiovascular Hospital
Collaborator
The General Hospital of Northern Theater Command
Collaborator
The First Hospital of Hebei Medical University
Collaborator
Qilu Hospital of Shandong University
Collaborator
First Affiliated Hospital, Sun Yat-Sen University
Collaborator
Meizhou People's Hospital
Collaborator
Sichuan Provincial People's Hospital
Collaborator
Lanzhou University Second Hospital
Collaborator
Zibo Central Hospital
Collaborator
Southwest Hospital, China
Collaborator
Second Xiangya Hospital of Central South University
Collaborator
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