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

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

Overview

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

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).

Interventions

• Device Active Comparator
  Percutaneously occlusion of PFO with Cardi-o-fix PFO occluder
• Device Experimental
  Transcatheter closure of a patent foramen ovale (PFO) with biodegradable PFO occluder

Primary outcome measures

• Success rate of effective occlusion [Time frame: at 12 months post-implantation]

Secondary outcome measures (9)

• Success rate of effective occlusion [Time frame: at 6 months post-implantation]
• Device Success Rate [Time frame: immediately after the procedure]
• Procedural success Rate [Time frame: 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]
• All-cause mortality [Time frame: 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]
• Incidence of device-related serious adverse events [Time frame: From attempted procedure up to 12 months post-implantation]
• Device defects [Time frame: From attempted procedure up to 12 months post-implantation]
• Migraine Headache events [Time frame: At 6 months and 12 months post-implantation]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07300358 · ShanghaiLingsiMedTech

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗