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.
Trial summary
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. Read more about this study
- 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
- Are there results?
- Not yet: the study is under way
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.
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Shenzhen Bihe Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital, Fuwai Yunnan Cardiovascular Hospital, The General Hospital of Northern Theater Command, The First Hospital of Hebei Medical University, Qilu Hospital of Shandong University, First Affiliated Hospital, Sun Yat-Sen University, Meizhou People's Hospital, Sichuan Provincial People's Hospital, Lanzhou University Second Hospital, Zibo Central Hospital, Southwest Hospital, China, Second Xiangya Hospital of Central South University
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07726927
- Acronym / sponsor ID
- C-BHP501-01
- Conditions
- Patent Foramen Ovale (PFO)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Shenzhen Bihe Medical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital, Fuwai Yunnan Cardiovascular Hospital, The General Hospital of Northern Theater Command, The First Hospital of Hebei Medical University, Qilu Hospital of Shandong University, First Affiliated Hospital, Sun Yat-Sen University, Meizhou People's Hospital, Sichuan Provincial People's Hospital, Lanzhou University Second Hospital, Zibo Central Hospital, Southwest Hospital, China, Second Xiangya Hospital of Central South University
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jul 2032 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PFO Suture System | Experimental | Device: Patent Foramen Ovale Suture System |
| Amplatzer PFO Occluder | Other | Device: Amplatzer PFO Occluder |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patent Foramen Ovale Suture SystemIn 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. | Device | PFO Suture System |
| Amplatzer PFO OccluderIn 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. | Device | Amplatzer PFO Occluder |
Primary outcome
Successful occlusion rate at 360 days postoperatively
Time frame: 360 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Quan Bingrui (+8613263266196, quanbingrui@lifetechmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful occlusion rate at 360 days postoperatively (time frame: 360 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.