Patent foramen ovale (PFO) is the most common cause of right-to-left shunt (RLS) in the adult heart, with a prevalence of approximately 25% in the general population. Extensive research has demonstrated an association between PFO and neurological conditions such as cryptogenic stroke, migraine, and sleep apnea syndrome, and it is even considered a potential root cause of these disorders. However, the mechanisms by which PFO contributes to neurological diseases remain unclear. In our preliminary clinical work, we have observed a strong correlation between PFO and epilepsy, and PFO closure has shown some efficacy in reducing seizure frequency. The aim of this study is to further investigate the efficacy and safety of PFO closure in patients with drug-resistant epilepsy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
180
patent foramen ovale closure
Westchina Hospital
Chengdu, Sichuan, China
RECRUITINGPercentage decrease in seizure frequency compared to baseline period
Percentage decrease in seizure frequency compared to baseline period
Time frame: Week 48
Percentage decrease in mean duration of seizures from baseline period
Percentage decrease in mean duration of seizures from baseline period
Time frame: Week 48
Percentage of decrease from baseline in Epilepsy Severity
Percentage of decrease from baseline in Epilepsy Severity Scale score (NHS3)
Time frame: Week 48
Percentage improvement from baseline in Quality of Life for Patients with Epilepsy
Percentage improvement from baseline in Quality of Life Rating Scale for Patients with Epilepsy (QOLIE-31)
Time frame: Week 48
The maximum number of observation days without sustained epileptic seizures during the follow-up observation period
The maximum number of observation days without sustained epileptic seizures during the follow-up observation period
Time frame: Up to 48 weeks
The proportion of subjects whose seizure frequency decreased by more than 50% compared to the baseline period
The proportion of subjects whose seizure frequency decreased by more than 50% compared to the baseline period
Time frame: Week 48
The proportion of subjects whose average duration of epileptic seizures decreased by more than 50% compared to the baseline period
The proportion of subjects whose average duration of epileptic seizures decreased by more than 50% compared to the baseline period
Time frame: Week 48
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