This trial has been completed.

Conditions epilepsy, asystole, cardiac arrhythmias
Treatment implantable heart rate monitor
Sponsor Stichting Epilepsie Instellingen Nederland
Collaborator Fonds NutsOhra
Start date June 2013
End date December 2016
Trial size 49 participants
Trial identifier NCT01946776, 1201-071


Patients with difficult-to-treat epilepsy ("refractory epilepsy") are at high risk of sudden death: sudden unexpected death in epilepsy (SUDEP). Cardiac arrhythmias are one of the possible causes of SUDEP. When monitoring in the hospital setting, the frequency of cardiac arrhythmias in people with epilepsy is low: 0,4%. However, when a subcutaneous implantable device (Reveal XT) is used to monitor heart rhythm continuously for an extended period of time, the frequency of clinically relevant arrhythmias appeared much higher in two small observational studies (n=19): 6-20%. The aim of this study is to analyze the frequency and underlying mechanism of cardiac arrhythmias in a larger group of 50 people with refractory epilepsy with Reveal XT. In the future, this may help us to identify those epilepsy patients at high risk of cardiac arrhythmias, so that we can timely institute preventive measures (e.g. pacemaker implantation).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
People with drug-resistant epilepsy whose heart rhythm will be monitored continuously for 2 years using Reveal XT, an implantable heart rate monitor.
implantable heart rate monitor Reveal XT
Implantation of Reveal XT

Primary Outcomes

Incidence and two-year prevalence of clinically relevant cardiac arrhythmia.
time frame: Continuously for two years or until the end-of-battery-life of Reveal XT (this period is expected to last an additional six months on average)

Secondary Outcomes

the number of patients who will have received a permanent pacemaker at the end of this study.
time frame: Continuously for two years or until the end-of-battery-life of Reveal XT (this period is expected to last an additional six months on average)

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: - Drug-resistant focal epilepsy: failure of adequate trials of two tolerated and appropriately chosen and used antiepileptic drug (AED) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom [16] - ≥ 1 complex partial and/or generalized tonic clonic seizure/month as indicated by history taking - If female, not pregnant - Aged 18 to 60 years - Able to undergo the study procedure as judged by the treating physician. Exclusion Criteria: - Clinical suspicion of seizure-induced asystole (e.g. seizures with sudden flaccid falls) - Reveal implantation (either present or in the past) - Known clinical relevant structural cardiac disease - Hereditary syndromes that increase the risk of cardiomyopathy (e.g. Marfan's disease) - ECG findings suggestive of arrhythmias without proper cardiac evaluation to in- or exclude this possibility. According to European Society of Cardiology (ESC) guidelines on syncope the following ECG findings will be used: bifascicular block and other intraventricular conduction abnormalities, asymptomatic inappropriate sinus bradycardia (<50 bpm), sinoatrial block or sinus pause ≥3s in the absence of negative chronotropic medications, non-sustained VT, pre-exited QRS complexes, prolonged or short QT interval, Brugada pattern, pattern suggestive of arrhythmogenic right ventricular cardiomyopathy. - Pacemaker - Use of beta blockers or other anti-arrhythmic/anti-arrhythmogenic medication - Previous diagnosis of psychogenic non-epileptic seizures - Patients who live alone and are not able to recall their seizures

Additional Information

Official title Cardiac Arrhythmias in Refractory Epilepsy: Identifying Prevalence and LINKage Between Seizures and Arrhythmias
Principal investigator Roland D Thijs, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Stichting Epilepsie Instellingen Nederland.