Closing a heart opening to treat drug-resistant epilepsy

Efficacy and Safety of Percutaneous Foramen Ovale Closure in Adult Patients with Drug-resistant Epilepsy and Patent Foramen Ovale: a Randomized Controlled Trial

This study is testing if closing a small heart opening can help people with drug-resistant epilepsy have fewer seizures.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Sichuan University (Academic / other)
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06863350 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of closing the patent foramen ovale (PFO) in patients suffering from drug-resistant epilepsy. The research is based on preliminary findings that suggest a correlation between PFO and epilepsy, with potential improvements in seizure frequency following PFO closure. Participants will undergo a procedure to close the PFO, and their seizure activity will be monitored over time to assess the treatment's effectiveness. The study aims to provide more definitive evidence on whether this intervention can benefit patients who have not responded to traditional epilepsy medications.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 60 with a diagnosis of drug-resistant epilepsy and confirmed patent foramen ovale.

Not a fit: Patients who do not have drug-resistant epilepsy or do not meet the criteria for patent foramen ovale may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce seizure frequency in patients with drug-resistant epilepsy.

How similar studies have performed: Preliminary studies have shown some success in using PFO closure for reducing seizure frequency, but this specific approach is still being evaluated.

Eligibility criteria

Inclusion Criteria:

1. Age between 18 and 60 years, with no gender restrictions;
2. Diagnosis of epilepsy in accordance with the International League Against Epilepsy (ILAE) criteria (2014 edition);
3. Drug-resistant epilepsy, defined as failure to achieve sustained seizure freedom despite appropriate selection and tolerability of at least two antiseizure medications (monotherapy or combination therapy) for a minimum of six months;
4. Diagnosis of patent foramen ovale (PFO) meeting the criteria established by the American Society of Echocardiography (ASE) and the Society for Cardiovascular Angiography and Interventions (SCAI) (2015 edition), with right-to-left shunting (RLS) of grade II or higher upon Valsalva maneuver, as assessed by contrast-enhanced echocardiography;
5. Stable antiseizure medication regimen for at least four weeks prior to screening, with willingness to maintain a stable regimen throughout the study period;
6. At least one documented seizure episode during a six-week screening period (with a minimum of four weeks of effective seizure diary recordings) and a retrospective self-reported history of at least 12 seizures in the year preceding screening;
7. Ability to independently or with caregiver assistance complete a seizure diary and comply with clinical data collection and required medical examinations;
8. Willingness to undergo the investigational treatment and voluntary provision of written informed consent.

Exclusion Criteria:

1. Patients diagnosed with epilepsy of a known etiology, including infectious, metabolic, immune, genetic, or structural causes;
2. History of stroke or psychogenic nonepileptic seizures (PNES);
3. History of epilepsy surgery or implantable neurostimulation therapy, or planned epilepsy surgery, neurostimulation therapy, ketogenic diet therapy, or other antiseizure interventions during the study period;
4. Presence of structural cardiac abnormalities other than patent foramen ovale (PFO), such as moderate or severe valvular regurgitation or pulmonary hypertension;
5. Presence of severe central nervous system (CNS) diseases, including acute cerebrovascular disease, intracranial tumors, intracranial infections, or progressive CNS disorders;
6. Evidence of vascular puncture site infection or difficulty with puncture as assessed by transesophageal echocardiography combined with contrast-enhanced right heart echocardiography;
7. Documented contraindications to antiplatelet therapy;
8. Presence of severe psychiatric disorders, such as schizophrenia, bipolar disorder, or severe depression or anxiety;
9. History of alcohol or other substance abuse;
10. Severe dysfunction of vital organs (heart, lungs, liver, kidneys) deemed by the investigator to pose a risk to the participant or impair the participant's ability to complete the study;
11. Pregnant or breastfeeding women, or women planning to conceive during the study period;
12. Participation in another interventional clinical trial within three months prior to signing the informed consent form, current participation in another interventional trial, or plans to participate in another interventional trial during the study period; inability to comply with follow-up due to travel or relocation;
13. Any other condition that the investigator determines makes the patient unsuitable for participation in this study.

Where this trial is running

Chengdu, Sichuan

• Westchina Hospital — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Lei Chen

Conditions Epilepsy; patent foramen ovale; epielpsy