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

Completed

• Conditions: Epilepsy

• Registration Number: NCT03376087
• Lead Sponsor: National Research Center for Preventive Medicine

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-16
• Study First Submitted: 2017-11-28
• Study First Submitted QC: 2017-12-15
• Study First Posted: 2017-12-18
• Primary Completion: 2019-12-15
• Study Completion: 2019-12-15
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-03
• Last Update Posted: 2020-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 193

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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