Inclusion criteria |
1. Subject is aged between 16 and 60 years old. |
2. Subject is diagnosed of PFO with right-to-left shunt, confirmed by Transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE) with agitated saline contrast. |
3. Subject is diagnosed of right-to-left shunt, confirmed by transcranial doppler with agitated saline contrast. |
4. Subject is diagnosed of migraine without identifiable cause of headache. |
5. Subject signs an informed Consent Form and is willing to participate in follow-up visits; 6. Primary and secondary endpoints. |
Exclusion criteria: |
1. Subject is diagnosed of headache with clear etiology. |
2. Subject had cerebral hemorrhage, bleeding events in other organs within 3 months or was in high risk of bleeding. |
3. Subject presents with ischemic lesions as indicated by brain CT/MR imaging. |
4. Subject is diagnosed of hepatic insufficiency: ALT or AST > 3 × ULN at the screening visit. |
5. Subject is diagnosed of moderate to severe renal insufficiency: eGFR < 30 ml/min/1.73m2 at the screening visit. |
6. Subject has uncontrolled arrhythmia with clinical significance within 90 days. |
7. Subject is diagnosed of unstable angina, severe coronary atherosclerosis or myocardial infarction within 90 days. |
8. Subject is diagnosed of pulmonary artery embolism, peripheral artery embolism or deep Vein Thrombosis. |
9. Subject cannot follow the study procedure due to other acute or chronic diseases. |
10. Subject is pregnant or lactating. |
11. Subject is under other RCT. |
12. Subject has a life expectancy < 1 year. |
13. Subject cannot follow the study procedure due to other reasons in the opinion of the investigators. |