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Cardiac Rhythm Disturbances in Hard-to-treat Epilepsy Patients Using Loop ECG Recorders (Epi-Loop-Rec)

N

National Research Center for Preventive Medicine

Status

Completed

Conditions

Epilepsy

Study type

Observational

Funder types

Other

Identifiers

NCT03376087
09-04/15 - 6

Details and patient eligibility

About

Seizure-related cardiac arrhythmias are one of the possible causes of sudden unexpected death in epilepsy (SUDEP). Identification of these patients is challenging because cardiac rhythm disturbances could emerge only during seizures. Furthermore, patients could have transitioned sinus or AV node blocks which could cause syncopes with brady-related seizures which could be treated as epilepsy-related seizures. Implantable loop recorders have an ability to recording single-channel ECG for up to 36 months which give an ability to detect these heart disturbances.

The purpose of this study is to look the incidence and types of arrhythmias which occur in 150 patients with hard-to-treat partial seizures and secondarily generalized seizures

Enrollment

193 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Hard-to-treat focal epilepsy
  2. Aged 18 to 60 years
  3. If female not pregnant

Exclusion criteria

  1. Known clinical relevant structural cardiac disease
  2. Implanted pacemaker, including cardiac resynchronisation device, or defibrillator
  3. Use of beta blockers or other antiarrhythmic medication
  4. Diagnosis of psychogenic non-epileptic seizures

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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