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Cardiovascular DiseasesBIOCLOSE-PFONCT07300358

Study on the Safety and Effectiveness of a Biodegradable Patent Foramen Ovale Occluder System

A study testing Active Comparator and Experimental in people with Cardiovascular Diseases and Cardiovascular Abnormality, run by Shanghai Lingsi Medical Technology 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

To evaluate the Safety and Efficacy of a Novel Biodegradable Occluder for Percutaneous Closure of Patent Foramen Ovale (PFO) Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Active Comparator and Experimental
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
258 participants
Where
No sites listed yet
Study dates
30 Dec 2025to 30 Jun 2027
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

  • Aged between 18 and 65 years.
  • Presence of a patent foramen ovale (PFO) confirmed by transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE).
  • Presence of a moderate-to-large right-to-left shunt (RLS) at rest or during the Valsalva maneuver, as confirmed by agitated saline contrast echocardiography (also known as bubble study).
  • Clinically diagnosed with a PFO-associated ischemic stroke or transient ischemic attack (TIA).

Who cannot join

  • An alternative, clearly identified cause of ischemic stroke or TIA (other than PFO) is determined by the investigator.
  • Large territory cerebral infarction within 4 weeks prior to the planned procedure.
  • Atherosclerotic stenosis (>50%) of the carotid or vertebral arteries, as confirmed by CT angiography or vascular ultrasound per investigator assessment.
  • Presence of intracardiac thrombus or vegetation as confirmed by echocardiography.
  • Left ventricular ejection fraction (LVEF) < 35%.
  • Atrial fibrillation or atrial flutter.
Show all 23Show fewer
  • Left ventricular aneurysm or severe regional wall motion abnormality.
  • Significant valvular stenosis or regurgitation, or history of valvular replacement or repair surgery.
  • Pulmonary hypertension or a PFO constituting a special conduit (e.g., right-to-left shunt due to elevated right heart pressures).
  • Other confirmed causes of right-to-left shunt, such as atrial septal defect (ASD) or pulmonary arteriovenous fistula.
  • Complex PFO anatomy (e.g., multi-tunnel PFO) or PFO associated with an ASD requiring different closure strategy.
  • Thrombus, mass, or vegetation identified at the intended implant site or along the potential delivery pathway.
  • Acute myocardial infarction or unstable angina within 3 months prior to the procedure.
  • Previous implantation of an inferior vena cava filter, PFO closure device, or ASD closure device.
  • Any other condition deemed by the investigator to make the patient unsuitable for PFO device implantation.
  • Concomitant cardiac anomalies requiring surgical correction.
  • Uncontrolled systemic or local infection, or sepsis.
  • Active infection requiring concurrent antibiotic therapy (Patients with transient conditions may be enrolled after completing antibiotic therapy and a subsequent 14-day washout period).
  • Contraindication to antiplatelet or anticoagulant therapy (e.g., major bleeding within 3 months, known retinopathy, history of intracranial hemorrhage, or other significant intracranial pathology).
  • Known hypersensitivity or allergy to tantalum or nickel.
  • Pregnancy, lactation, or women of childbearing potential not using highly effective contraception.
  • Life expectancy less than 1 year due to malignancy or other comorbid disease.
  • Current participation in another investigational drug or device clinical study that has not yet completed its primary endpoint.

Trial locations and contacts

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

XiangBin Pan, Doctor contact

13811763898

xiangbin428@hotmail.com

Wenbin Ouyang, Doctor contact

About this study

Official title: BIOCLOSE-PFO Study：Evaluation of the Safety and Efficacy of a Biodegradable Patent Foramen Ovale Occluder System: A Prospective, Multicenter, Randomized Controlled, Non-Inferiority Clinical Study

To evaluate the Safety and Efficacy of a Novel Biodegradable Occluder for Percutaneous Closure of Patent Foramen Ovale (PFO)

Read the detailed description

This is a prospective, multicenter, randomized, controlled, non-inferiority clinical study. The study aims to evaluate the safety and efficacy of a novel biodegradable patent foramen ovale (PFO) occluder system compared to a conventional metallic occluder in patients with a PFO that is clinically determined to be associated with an PFO⁃associated stroke（PFO-AS）or transient ischemic attack (TIA).

Being tested
Active Comparator, Experimental
Medical subject headings
Cardiovascular Diseases, Cardiovascular Abnormalities, Heart Defects, Congenital, Heart Septal Defects, Heart Septal Defects, Atrial, Foramen Ovale, Patent, Ischemic Stroke, Stroke

What participants receive

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

  • Active ComparatorDevice

    Also called Cardi-o-fix PFO occluder

    Percutaneously occlusion of PFO with Cardi-o-fix PFO occluder

  • ExperimentalDevice

    Transcatheter closure of a patent foramen ovale (PFO) with biodegradable PFO occluder

Study groups in NCT07300358
Study groupRoleWhat they receive
Cardi-o-fix PFO occluderActive comparatorParticipants treated with th with the Cardi-o-fix PFO occluder according to the INSTRUCTIONS for Use (IFU)
Receives: Device: Active Comparator
Biodegradable PFO occluder systemExperimentalParticipants treated with th with the biodegradable PFO occluder system according to the INSTRUCTIONS for Use (IFU)
Receives: Device: Experimental

What is being measured

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

  1. Success rate of effective occlusion

    Effective occlusion was defined as: 12 months after the procedure, Echocardiographyshowed that the position and shape of the occluder were normal, and no horizontal atrial shunt was observed. Re-examination by Contrast echocardiography (cTTE or cTEE) showed no or only a small amount of right-to-left shunt, that is, no microvesicles or less than 10 microvesicles/frame in left heart cavity after Valsalva and resting state.

    Measured: at 12 months post-implantation

Secondary outcomes (9)

  1. Success rate of effective occlusion

    Effective occlusion was defined as: 6 months after the procedure, Echocardiographyshowed that the position and shape of the occluder were normal, and no horizontal atrial shunt was observed. Re-examination by Contrast echocardiography (cTTE or cTEE) showed no or only a small amount of right-to-left shunt, that is, no microvesicles or less than 10 microvesicles/frame in left heart cavity after Valsalva and resting state.

    Measured: at 6 months post-implantation

  2. Device Success Rate

    Successful intraoperative deployment of the occluder, with immediate post-procedure echocardiography confirming appropriate device morphology and position, absence of new pericardial effusion or valvular regurgitation, and successful retrieval of the delivery system

    Measured: immediately after the procedure

  3. Procedural success Rate

    Successful device implantation without any procedure- or device-related complications prior to discharge. Complications include atrial fibrillation, other serious arrhythmic events, thrombosis, cerebral embolism, pericardial effusion, cardiac tamponade, device embolization, or displacement

    Measured: at discharge or 7 days post-procedure

  4. Recurrence or incidence of cryptogenic stroke or TIA

    Cryptogenic stroke was defined as a new focal cerebral ischemia confirmed by neuroimaging (cranial MRI or CT), which was performed After extensive vascular, cardiac, and blood evaluation, non-atherosclerotic, cardiogenic, or arteriolar obliterators were identified Cerebral infarction caused by the diagnosis of exclusion.

    Measured: From attempted procedure up to 12 months post-implantation

  5. All-cause mortality

    All-cause death is defined as death from any cause during the follow-up period

    Measured: From attempted procedure up to 12 months post-implantation

  6. Incidence of new atrial fibrillation and atrial flutter

    atrial fibrillation and atrial flutter

    Measured: From attempted procedure up to 12 months post-implantation

  7. Incidence of device-related serious adverse events

    including but not limited to: Device-related thrombosis、embolic stroke、peripheral arterial embolism、Ⅲ° atrioventricular block、cardiac erosion、infective endocarditis、severe hemolytic anemia

    Measured: From attempted procedure up to 12 months post-implantation

  8. Device defects

    Device defects refer to unreasonable risks that may endanger human health and safety under normal use of medical devices in clinical trials, such as label errors, quality problems and failures.

    Measured: From attempted procedure up to 12 months post-implantation

  9. Migraine Headache events

    Change in the number of monthly migraine days from baseline to 6 months and 12 months.

    Change in the number of migraine attacks from baseline to 6 months and 12 months.

    Change in the Score of HIT-6 or VAS or MIDAS from baseline to 6 months and 12 months.

    Measured: At 6 months and 12 months post-implantation

Timeline

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

  1. First posted23 Dec 2025
  2. Study start30 Dec 2025 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
258 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07300358
Sponsor's protocol ID
ShanghaiLingsiMedTech
Acronym
BIOCLOSE-PFO
Status last verified
Dec 2025
First submitted
15 Sep 2025
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Active Comparator and Experimental in people with Cardiovascular Diseases and Cardiovascular Abnormality, run by Shanghai Lingsi Medical Technology 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 23 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 23 Dec 2025. 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 XiangBin Pan, Doctor (13811763898, xiangbin428@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success rate of effective occlusion (time frame: at 12 months post-implantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07300358.

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 23 Dec 2025.

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