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

Prospective, Multicenter, Randomized Controled, Non-inferiority Clinical Study to Evaluate the Efficacy and Safety of the Patent Foramen Ovale Suture System for the Closure of Patent Foramen Ovale

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Patent Foramen Ovale (PFO)
• Intervention / Treatment: Device: Patent Foramen Ovale Suture System; Device: Amplatzer PFO Occluder

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 244
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Quan Bingrui; Phone Number: +8613263266196; Email: quanbingrui@lifetechmed.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The subject is aged between 18 and 65 years old;
2. 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);
3. Diagnosed as PFO-related stroke/TIA after clinical exclusion of other etiologies;
4. 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:

1. Carotid atherosclerotic stenosis (stenosis degree >50% confirmed by ultrasound or CTA);
2. 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));
3. Intracardiac thrombus or tumor, intracardiac vegetation;
4. Acute myocardial infarction or unstable angina within 6 months;
5. Presence of left ventricular aneurysm or left ventricular wall motion abnormality;
6. Severe valvular heart disease, such as severe mitral regurgitation or stenosis, severe aortic regurgitation or stenosis, mitral or aortic valve vegetation;
7. Combined cardiomyopathy (including hypertrophic cardiomyopathy, restrictive cardiomyopathy, dilated cardiomyopathy, etc.);
8. Severe heart failure with LVEF <35%;
9. Pulmonary hypertension (mPAP >25 mmHg);
10. Right-to-left shunt caused by other etiologies, including atrial septal defect or pulmonary arteriovenous fistula;
11. Concomitant atrial fibrillation or atrial flutter;
12. Active endocarditis or other untreated infections;
13. Thrombosis in the access vessel or conditions interfering with the normal deployment of the study device;
14. 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);
15. Coagulopathy or contraindications to antiplatelet or anticoagulant therapy;
16. Pregnant or lactating females, or those planning pregnancy during the trial period;
17. 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;
18. Malignant tumor or other diseases with life expectancy less than 1 year;
19. Participation in another clinical trial with trial endpoints not yet reached;
20. Other conditions deemed inappropriate for enrollment in this trial by the investigator.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PFO Suture System	Device: Patent Foramen Ovale Suture System; In 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.
Other: Amplatzer PFO Occluder	Device: Amplatzer PFO Occluder; In 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Successful occlusion rate at 360 days postoperatively	360 days postoperatively

Collaborators and Investigators

• Sponsor: Shenzhen Bihe Medical Co., Ltd
• Collaborators: First Affiliated Hospital, Sun Yat-Sen University; Southwest Hospital, China; Qilu Hospital of Shandong University; Chinese Academy of Medical Sciences, Fuwai Hospital; Second Xiangya Hospital of Central South University; The First Hospital of Hebei Medical University; Sichuan Provincial People's Hospital; Zibo Central Hospital; Meizhou People's Hospital; Lanzhou University Second Hospital; Fuwai Yunnan Cardiovascular Hospital; The General Hospital of Northern Theater Command

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): July 31, 2032

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 27, 2026

Study Record Updates

• Last Update Posted (Actual): July 27, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital; Heart Septal Defects, Atrial; Heart Septal Defects; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Foramen Ovale, Patent
• Other Study ID Numbers: C-BHP501-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No