Patent foramen ovale
Conditions
Interventions
Experimental group: Biodegradable PFO occluder system
Control group:Metal PFO Occluder
Sponsors
Fuwai Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–65 years (inclusive); 2. Patent foramen ovale confirmed by transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE); 3. Right heart echocardiographic contrast study confirming moderate to large right-to-left shunt at rest or during Valsalva maneuver; 4. Clinically judged to have stroke or transient ischemic attack (TIA) related to patent foramen ovale (PFO); 5. Patient has been informed about the nature of this study, understands the purpose of the clinical trial, agrees to participate in this clinical trial, and voluntarily signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. As judged by the researcher, ischemic stroke or TIA with identifiable non-PFO-related causes; 2. Large-area cerebral infarction occurring within 4 weeks before surgery; 3. Carotid or vertebral artery atherosclerotic stenosis (>50% or moderate and above), as determined by the researcher based on the patient's CTA or vascular ultrasound; 4. Echocardiography suggesting the presence of intracardiac thrombus or mass; 5. Left ventricular ejection fraction (LVEF) <35%; 6. Atrial fibrillation or atrial flutter; 7. Left ventricular aneurysm formation or left ventricular wall motion abnormalities; 8. Severe valvular stenosis or regurgitation, or a history of valve replacement or repair surgery; 9. Pulmonary hypertension or PFO with special pathway (right-to-left heart failure); 10. Right-to-left shunt caused by other reasons, including atrial septal defect or pulmonary arteriovenous fistula; 11. Multi-patent PFO or PFO combined with atrial septal defect (ASD); 12. Thrombus, mass, or vegetation at the implant site or along the implantation path; 13. Acute myocardial infarction or unstable angina within 3 months before surgery; 14. Previous implantation of inferior vena cava filter, PFO closure device, or ASD closure device; 15. Situations deemed unsuitable for PFO closure by the researcher; 16. Other cardiac malformations requiring cardiac surgery; 17. Uncontrolled systemic or local infection, sepsis; 18. Active infection requiring concurrent antibiotic treatment (if a temporary condition, the patient must have stopped antibiotics for at least 14 days before enrollment); 19. Contraindications to antiplatelet or anticoagulant therapy, such as severe bleeding within the past 3 months; documented retinal disease, history of intracranial hemorrhage, or known intracranial disease; 20. Allergy to tantalum or nickel; 21. Pregnant or breastfeeding women; 22. Malignant tumors or other diseases with an expected life expectancy of less than 1 year; 23. Patients currently participating in an experimental drug or medical device clinical study whose primary endpoints have not yet been completed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of effective occlusion at 12 months post-procedure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of effective occlusion at 12 months post-procedure;Device Success Rate;Procedural success Rate;Recurrence or incidence of cryptogenic stroke or TIA;All-cause mortality;incidence of new atrial fibrillation and atrial flutter;Incidence of device-related serious adverse events;Incidence of device defects; | — |
Countries
China
Contacts
Public ContactXiangbin Pan
Fuwai Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed