Patent Foramen Ovale (PFO)NCT07726927

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

A study testing Patent Foramen Ovale Suture System and Amplatzer PFO Occluder in people with Patent Foramen Ovale (PFO), run by Shenzhen Bihe Medical Co., Ltd.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Patent Foramen Ovale (PFO)
What is being tested?: Patent Foramen Ovale Suture System and Amplatzer PFO Occluder
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 244 participants
Where: No sites listed yet
Study dates: 30 Jun 2026to 31 Jul 2032
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Quan Bingrui contact

+8613263266196

quanbingrui@lifetechmed.com

About this study

Official title: 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.

Read the 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.

Conditions: Patent Foramen Ovale (PFO)
Being tested: Patent Foramen Ovale Suture System, Amplatzer PFO Occluder
Medical subject headings: Foramen Ovale, Patent

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Patent Foramen Ovale Suture SystemDevice
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.
Amplatzer PFO OccluderDevice
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.

Study groups in NCT07726927
Study group	Role	What they receive
PFO Suture System	Experimental	Not described Receives: Device: Patent Foramen Ovale Suture System
Amplatzer PFO Occluder	Other	Not described Receives: Device: Amplatzer PFO Occluder

What is being measured

The primary outcome is the main question the study is designed to answer.

Successful occlusion rate at 360 days postoperatively
Measured: 360 days postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jun 202631 Jul 2032

First posted27 Jul 2026
Study start30 Jun 2026 (estimated)
Primary completion31 Dec 2027 (estimated)
Study completion31 Jul 2032 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Patent Foramen Ovale (PFO)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 244 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07726927
Sponsor's protocol ID: C-BHP501-01
Status last verified: Jul 2026
First submitted: 21 Jul 2026
Last updated: 27 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Quan Bingrui

+8613263266196

quanbingrui@lifetechmed.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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The Cardiovascular Effects of Patent Foramen Ovale in Hypoxia
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GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study
Stroke, PFO - Patent Foramen Ovale

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