Study on the Safety and Effectiveness of a Biodegradable Patent Foramen Ovale Occluder System (BIOCLOSE-PFO)

December 9, 2025 updated by: Shanghai Lingsi Medical Technology Co., Ltd.

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
258

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Wenbin Ouyang, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Cardi-o-fix PFO occluder
Participants treated with th with the Cardi-o-fix PFO occluder according to the INSTRUCTIONS for Use (IFU)
Device: Active Comparator
Percutaneously occlusion of PFO with Cardi-o-fix PFO occluder
Other Names:
  • Cardi-o-fix PFO occluder
Experimental: Biodegradable PFO occluder system
Participants treated with th with the biodegradable PFO occluder system according to the INSTRUCTIONS for Use (IFU)
Device: Experimental
Transcatheter closure of a patent foramen ovale (PFO) with biodegradable PFO occluder

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Success rate of effective occlusion
Time Frame: at 12 months post-implantation
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.
at 12 months post-implantation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Success rate of effective occlusion
Time Frame: at 6 months post-implantation
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.
at 6 months post-implantation
Device Success Rate
Time Frame: immediately after the procedure
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
immediately after the procedure
Procedural success Rate
Time Frame: at discharge or 7 days post-procedure
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
at discharge or 7 days post-procedure
Recurrence or incidence of cryptogenic stroke or TIA
Time Frame: From attempted procedure up to 12 months post-implantation
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.
From attempted procedure up to 12 months post-implantation
All-cause mortality
Time Frame: From attempted procedure up to 12 months post-implantation
All-cause death is defined as death from any cause during the follow-up period
From attempted procedure up to 12 months post-implantation
Incidence of new atrial fibrillation and atrial flutter
Time Frame: From attempted procedure up to 12 months post-implantation
atrial fibrillation and atrial flutter
From attempted procedure up to 12 months post-implantation
Incidence of device-related serious adverse events
Time Frame: From attempted procedure up to 12 months post-implantation
including but not limited to: Device-related thrombosis、embolic stroke、peripheral arterial embolism、Ⅲ° atrioventricular block、cardiac erosion、infective endocarditis、severe hemolytic anemia
From attempted procedure up to 12 months post-implantation
Device defects
Time Frame: From attempted procedure up to 12 months post-implantation
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.
From attempted procedure up to 12 months post-implantation
Migraine Headache events
Time Frame: At 6 months and 12 months post-implantation

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.
At 6 months and 12 months post-implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Lingsi Medical Technology Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: XiangBin Pan, Doctor, Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ShanghaiLingsiMedTech

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings