Patent foramen ovale
Conditions
Interventions
Nitinol occluder group:None
Bioabsorbable occluder group:None
Sponsors
Shanghai East Hospital, School of Medicine, Tongji University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1: Agreed to be enrolled and voluntarily signed the informed consent form; 2: PFO patients with preoperative diagnosis of grade II-III flow by transthoracic ultrasound (TTE) or transesophageal echocardiography (TEE); 3: Consent for percutaneous patent foramen ovale occlusion with metal occluder or degradable PFO occluder; 4: Hidden ischemic stroke, migraine, dizziness or other recurrent neurologic and psychiatric symptoms; 5: All patients between the ages of 18 and 75 years who did not benefit from conventional drug therapy.
Exclusion criteria
Exclusion criteria: 1: Other known causes of migraine; 2: Cerebral infarction with known cause; 3: Contraindication to antiplatelet or anticoagulation therapy; 4: Massive cerebral infarction within 4 weeks; 5: Inferior vena cava or pelvic vein thrombosis, systemic or localized infection, sepsis, intracardiac thrombosis; 6: Planned pregnancy, pregnancy and lactation; 7: Combined pulmonary hypertension or PFO as a survival route; 8: Patients with serious co-morbidities: e.g., other serious systemic diseases (e.g., severe cardiovascular disease, renal failure, serious infections, etc.) that may affect the study results (abnormal liver function, hyperthyroidism, hypothyroidism, diabetes mellitus, autoimmune diseases); 9: Patients whose participation in other clinical trials affects this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Migraine severity score (Hit-6, Midas, frequency, duration, etc.); | — |
Secondary
| Measure | Time frame |
|---|---|
| Potential predictors of migraine improvement after percutaneous PFO closure with PFO occluder;Perioperative complications include severe bleeding, cardiac tamponade, device embolism, and procedure-related stroke, as well as all-cause death, arrhythmia (atrial fibrillation/atrial flutter);Operation Time, exposure time and dose of radiation; | — |
Countries
China
Contacts
Public ContactLinxiang Lu
Shanghai East Hospital, School of Medicine, Tongji University
Outcome results
None listed