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

N/ANot Yet RecruitingNCT07300358

Shanghai Lingsi Medical Technology Co., Ltd.258 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

258

Conditions

Cardiovascular Diseases Cardiovascular Abnormality Heart Defects, Congenital Heart Septal Defects

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: at 12 months post-implantation

Secondary Outcomes

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.

Time frame: 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

Time frame: 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

Time frame: 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.