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

NCT07300358 | Not Yet Recruiting

• 1 other identifier: ShanghaiLingsiMedTech
• Study Type: interventional
• Target: 258
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Cardiovascular Diseases; Stroke, Ischemic; Cardiovascular Abnormality; Heart Defects, Congenital; Heart Septal Defects; Heart Septal Defects, Atrial; Foramen Ovale, Patent; Stroke (CVA) or TIA

Outcome Measures

Primary Outcomes (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.

  at 12 months post-implantation

Secondary Outcomes (9)

• Success rate of effective occlusion

  at 6 months post-implantation

• Device Success Rate

  immediately after the procedure

• Procedural success Rate

  at discharge or 7 days post-procedure

• Recurrence or incidence of cryptogenic stroke or TIA

  From attempted procedure up to 12 months post-implantation

• All-cause mortality

  From attempted procedure up to 12 months post-implantation

Study Arms (2)

Cardi-o-fix PFO occluder

ACTIVE COMPARATOR

Participants treated with th with the Cardi-o-fix PFO occluder according to the INSTRUCTIONS for Use (IFU)

Device: Active Comparator

Biodegradable PFO occluder system

EXPERIMENTAL

Participants treated with th with the biodegradable PFO occluder system according to the INSTRUCTIONS for Use (IFU)

Device: Experimental

Interventions

Active Comparator DEVICE

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

Also known as: Cardi-o-fix PFO occluder

Cardi-o-fix PFO occluder

Experimental DEVICE

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

Biodegradable PFO occluder system

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Lingsi Medical Technology Co., Ltd.: lead

MeSH Terms

Conditions

Cardiovascular Diseases; Cardiovascular Abnormalities; Heart Defects, Congenital; Heart Septal Defects; Heart Septal Defects, Atrial; Foramen Ovale, Patent; Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• XiangBin Pan, Doctor

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

XiangBin Pan, Doctor

CONTACT

13811763898; xiangbin428@hotmail.com

Wenbin Ouyang, Doctor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: December 23, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share