Effectivity and Safety of PFO Closure vs Medicine in Alleviating Migraine (NCT04946734) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Effectivity and Safety of PFO Closure vs Medicine in Alleviating Migraine
China440 participantsStarted 2021-08-12
Plain-language summary
Effectivity and safety of PFO closure vs medicine in alleviating migraine （SPRING）: a multicenter, random, case control study
Who can participate
Age range
16 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. Subject is diagnosed of headache with clear etiology.
. Subject had cerebral hemorrhage, bleeding events in other organs within 3 months or was in high risk of bleeding.
. Brain CT/MR showed ischemic lesions.
. 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.
. Subject has uncontrolled arrhythmia with clinical significance within 90 days.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Complete cessation of migraine
Timeframe: Month 12
2
Serious Adverse Event (SAE) related due to device, drug or study procedure