Actively Recruiting
Percutaneous Repair for Drug - Resistant Epilepsy by Intervention of Closing the Patent Foramen Ovale（PREDICT-PFO Trial）
Led by Sichuan University · Updated on 2025-03-11
180
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Percutaneous Repair for Drug - Resistant Epilepsy by Intervention of Closing the Patent Foramen Ovale（PREDICT-PFO Trial）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 60 years, with no gender restrictions
- Diagnosis of epilepsy according to the International League Against Epilepsy (ILAE) 2014 criteria
- Drug-resistant epilepsy, defined as failure to achieve seizure freedom after at least two antiseizure medications for a minimum of six months
- Diagnosis of patent foramen ovale (PFO) with right-to-left shunting grade II or higher confirmed by contrast-enhanced echocardiography
- Stable antiseizure medication regimen for at least four weeks before screening and willingness to maintain it during the study
- At least one seizure during a six-week screening period with minimum four weeks of seizure diary recordings and at least 12 seizures in the year before screening
- Ability to keep a seizure diary independently or with caregiver help and comply with medical examinations
- Willingness to undergo the investigational treatment and provide written informed consent
You will not qualify if you...
- Epilepsy caused by known factors such as infection, metabolic, immune, genetic, or structural causes
- History of stroke or psychogenic nonepileptic seizures (PNES)
- History or planned epilepsy surgery, neurostimulation therapy, ketogenic diet, or other antiseizure treatments during the study
- Structural heart problems other than PFO, including moderate or severe valve regurgitation or pulmonary hypertension
- Severe central nervous system diseases such as stroke, brain tumors, infections, or progressive disorders
- Infection or difficulty at vascular puncture site as shown by echocardiography
- Contraindications to antiplatelet therapy
- Severe psychiatric illnesses including schizophrenia, bipolar disorder, or severe depression or anxiety
- History of alcohol or substance abuse
- Severe dysfunction of vital organs judged unsafe for study participation
- Pregnant or breastfeeding women or those planning pregnancy during the study
- Participation in another interventional trial within three months before consent or during the study
- Any other condition deemed by the investigator to make participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Westchina Hospital
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
L
Lei Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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