Patent foramen ovale
Conditions
Interventions
Experimental group:Biodegradable patent foramen ovale plugging device and interventional conveying device
control group:A patent ovale plugging device and an integrated plugging device are inserted into the conveying device
Sponsors
Hefei Gaoxin Cardiovascular Disease Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18-65 (inclusive) years, gender unlimited; (2) The presence of PFO on echocardiography (TEE or TTE) or right-to-left shunt confirmed by contrast acoustic examination; (3) There is at least one of the following clinical conditions: a) Unexplained stroke (CS) or transient ischemic attack (TIA) complicated by PFO, with moderate to large RLS; b) Unexplained stroke (CS) or transient ischemic attack (TIA) complicated by PFO, but still relapsed with antiplatelet or anticoagulant therapy; c) Unexplained stroke (CS) or transient ischemic attack (TIA) complicated by PFO, with definite deep vein thrombosis (DVT) or pulmonary embolism (PE); d) Recumbent respiratory orthostatic hypoxemia with PFO, with moderate to large amounts of RLS; e) refractory or chronic migraine with PFO, with moderate to large RLS; f) PFO complicated with venous thrombosis or lower limb varicose vein/valvular insufficiency, with moderate or large RLS; g) High risk PFO, namely, Atrial septal aneurysm (ASA) or excessive septal activity, large PFO (diameter >= 4.0mm) and PFO with resting RLS. (4) Volunteered to participate in the clinical trial, and signed the informed consent of the subjects.
Exclusion criteria
Exclusion criteria: (1) Cerebral embolism of any cause can be found; (2) Antiplatelet or anticoagulant therapy contraindications, such as severe bleeding within 3 months, obvious retinopathy, other history of intracranial hemorrhage, obvious intracranial disease; (3) Complete obstruction due to thrombus of inferior vena cava or pelvic vein; (4) Systemic or local infection, sepsis; (5) Intracardiac thrombosis; (6) Patients with pulmonary hypertension or PFO as special channel; (7) Large cerebral infarction within 4 weeks; (8) Patients with nickel allergy; (9) Patients with right-to-left shunt due to other causes, including atrial septal defect or pulmonary arteriovenous fistula; (10) Pregnant or lactating women and those who planned to become pregnant during the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plugging success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Instrument success rate;Surgical success rate;Postoperative RLS grading; | — |
Countries
China
Contacts
Public ContactWeiyi Fang
Outcome results
None listed