Cardiac Rhythm Disturbances in Hard-to-treat Epilepsy Patients Using Loop ECG Recorders

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03376087

Acronym

Epi-Loop-Rec

Enrollment

193

Registered

2017-12-18

Start date

2015-11-16

Completion date

2019-12-15

Last updated

2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

Epilepsy, heart block, sudden cardiac death, loop recorder

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Identification of a dysrhythmia	3 years or until the end-of-battery life of Reveal XT, whichever came first	A dysrhythmia will be defined as either * asystole of ≥6 s * sinus bradycardia of ≤40 bpm during physical activity * 2nd or 3rd-degree AV-block * sinus tachycardia of ≥120 bpm * nonsustained and sustained monomorphic VT of ≥170 bpm * polymorphic VT * atrial fibrillation/flutter

Secondary

Measure	Time frame
The number of patients who will have receive the permanent pacemaker at the end of the study.	3 years or until the end-of-battery life of Reveal XT, whichever came first

Outcome results