CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 49 enrolled
Drug / intervention
implantable heart rate monitordevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01946776
NCT01946776N/ACompleted

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

Stichting Epilepsie Instellingen Nederland·interventional·Posted Sep 20, 2013·Updated Dec 26, 2016

In Brief

A clinical study evaluating implantable heart rate monitor for Epilepsy and 2 related conditions. Completed, enrolled 49 participants across 4 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNetherlands

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 20, 2013
Enrollment StartJun 1, 2013
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 12.8 years ago

Interventions

implantable heart rate monitordevice

Implantation of Reveal XT