NCT01946776

Cardiac Arrhythmias in Epilepsy: the CARELINK-study

Cardiac Arrhythmias in Refractory Epilepsy: Identifying Prevalence and LINKage Between Seizures and Arrhythmias

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Stichting Epilepsie Instellingen Nederland · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Epilepsy
• Asystole
• Cardiac Arrhythmias

Interventions

Type	Name	Description
DEVICE	implantable heart rate monitor	Implantation of Reveal XT

Timeline

• Start date: 2013-06-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2013-09-20
• Last updated: 2016-12-26

Locations

4 sites across 1 country: Netherlands