Percutaneous Repair for Drug - Resistant Epilepsy by Intervention of Closing the Patent Foramen Ovale(PREDICT-PFO Trial)

Last updated: March 9, 2025
Sponsor: Sichuan University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Epilepsy

Treatment

patent foramen ovale closure

Clinical Study ID

NCT06863350
HX20242572
ZYYC23011
  • Ages 18-60
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 freedomdespite appropriate selection and tolerability of at least two antiseizuremedications (monotherapy or combination therapy) for a minimum of six months;

  4. Diagnosis of patent foramen ovale (PFO) meeting the criteria established by theAmerican Society of Echocardiography (ASE) and the Society for CardiovascularAngiography and Interventions (SCAI) (2015 edition), with right-to-left shunting (RLS) of grade II or higher upon Valsalva maneuver, as assessed by contrast-enhancedechocardiography;

  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 aminimum of four weeks of effective seizure diary recordings) and a retrospectiveself-reported history of at least 12 seizures in the year preceding screening;

  7. Ability to independently or with caregiver assistance complete a seizure diary andcomply with clinical data collection and required medical examinations;

  8. Willingness to undergo the investigational treatment and voluntary provision ofwritten informed consent.

Exclusion

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 plannedepilepsy surgery, neurostimulation therapy, ketogenic diet therapy, or otherantiseizure 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 acutecerebrovascular disease, intracranial tumors, intracranial infections, orprogressive CNS disorders;

  6. Evidence of vascular puncture site infection or difficulty with puncture as assessedby transesophageal echocardiography combined with contrast-enhanced right heartechocardiography;

  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 theinvestigator to pose a risk to the participant or impair the participant's abilityto complete the study;

  11. Pregnant or breastfeeding women, or women planning to conceive during the studyperiod;

  12. Participation in another interventional clinical trial within three months prior tosigning the informed consent form, current participation in another interventionaltrial, or plans to participate in another interventional trial during the studyperiod; inability to comply with follow-up due to travel or relocation;

  13. Any other condition that the investigator determines makes the patient unsuitablefor participation in this study.

Study Design

Total Participants: 180
Treatment Group(s): 1
Primary Treatment: patent foramen ovale closure
Phase:
Study Start date:
February 28, 2025
Estimated Completion Date:
June 01, 2027

Connect with a study center

  • Westchina Hospital

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

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