Effectivity and Safety of PFO Closure vs Medicine in Alleviating Migraine

Más betegség

• Subject had cerebral hemorrhage, bleeding events in other organs within 3 months or was in high risk of bleeding.
• Subject has uncontrolled arrhythmia with clinical significance within 90 days.
• Subject is diagnosed of unstable angina, severe coronary atherosclerosis or myocardial infarction within 90 days.
• Subject is diagnosed of pulmonary artery embolism, peripheral artery embolism or deep Vein Thrombosis.
• Subject cannot follow the study procedure due to other acute or chronic diseases.

Laborértékek

• Subject is diagnosed of hepatic insufficiency: ALT or AST>3×ULN at the screening visit.
• Subject is diagnosed of moderate to severe renal insufficiency: eGFR<30ml/min/1.73m2 at the screening visit.

Egyéb

• Subject is diagnosed of headache with clear etiology.
• Brain CT/MR showed ischemic lesions.
• Subject is pregnant or lactating.
• Subject is under other RCT.
• Subject has a life expectancy <1 year.
• Subject cannot follow the study procedure due to other reasons in the opinion of the investigators.

• Presence of PFO with right-to-left shunt, confirmed by Transthoracic.
• Echocardiography (TTE) or transesophageal echocardiography (TEE) with a bubble study.
• Bubble study positive confirmed by transcranial doppler.
• Subject is diagnosed of migraine.
• Subject signs an informed Consent Form and is willing to participate in follow-up visits