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

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: Not yet recruiting
• Conditions: Cardiovascular Diseases; Heart Septal Defects; Heart Septal Defects, Atrial; Heart Defects, Congenital; Foramen Ovale, Patent; Stroke, Ischemic; Stroke (CVA) or TIA; Cardiovascular Abnormality
• Intervention / Treatment: Device: Active Comparator; Device: Experimental

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: Interventional
• Enrollment (Estimated): 258
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: XiangBin Pan, Doctor; Phone Number: 13811763898; Email: xiangbin428@hotmail.com
• Study Contact Backup: Name: Wenbin Ouyang, Doctor

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	at 12 months post-implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at 6 months post-implantation
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	immediately after the procedure
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	at discharge or 7 days post-procedure
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.	From attempted procedure up to 12 months post-implantation
All-cause mortality	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	atrial fibrillation and atrial flutter	From attempted procedure up to 12 months post-implantation
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	From attempted procedure up to 12 months post-implantation
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.	From attempted procedure up to 12 months post-implantation
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.	At 6 months and 12 months post-implantation

Collaborators and Investigators

• Sponsor: Shanghai Lingsi Medical Technology Co., Ltd.
• Investigators: Principal Investigator: XiangBin Pan, Doctor, Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 30, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: September 15, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ischemic Stroke; Stroke; Cardiovascular Diseases; Heart Defects, Congenital; Foramen Ovale, Patent; Heart Septal Defects; Heart Septal Defects, Atrial; Cardiovascular Abnormalities
• Other Study ID 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