Cardiac Arrhythmias in Epilepsy: the CARELINK-study
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 Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Cardiac Arrhythmias in Refractory Epilepsy: Identifying Prevalence and LINKage Between Seizures and Arrhythmias|
- 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) ] [ Designated as safety issue: No ]
Clinical relevant cardiac arrhythmia is defined as:
- Asystole of ≥ 6s together with clinical symptoms (lightheadedness, syncope, seizure) as indicated by seizure diary, activation of the portable seizure monitor, or patient activation of Reveal XT. The time frame between the reported clinical symptoms and the recorded event should not exceed 15 minutes.
- Asystole of ≥10s regardless of report of clinical symptoms
Other cardiac arrhythmias of clinical significance:
- polymorphic sustained or non-sustained ventricular tachycardia (VT)
- non-sustained monomorphic VT of >180 bpm and >2s duration, or >175 bpm and >3s duration, and sustained monomorphic VT
- atrial fibrillation (AF) of >200 bpm and >30s duration, or <55 bpm and clinical symptoms (dizziness or dyspnea)
- persistent sinus bradycardia of <40 bpm during physical activity
- asymptomatic 2nd or 3rd degree atrioventricular (AV) block of >4s duration
- 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) ] [ Designated as safety issue: No ]Participants who will exhibit a clinically relevant arrhythmia (see our primary endpoints) during this study will be referred to an independent cardiologist for further evaluation and/or treatment. In a certain number of cases, this cardiologist will decide with the patient that pacemaker implantation would be the appropriate cause of action.
- The percentage of seizure-related cardiac arrhythmias [ 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) ] [ Designated as safety issue: No ]The number of seizures during which a cardiac arrhythmia occurs divided by the total number of seizures during this study
- The percentage of patients with a cardioinhibitory response to head-up tilt-testing [ Time Frame: During one head-up tilt-test (approximate duration 1,5 hours) ] [ Designated as safety issue: No ]The number of patients with a cardioinhibitory response to head-up tilt-testing (1) heart rate rising initially then falling to a ventricular rate of <40 bpm for >10 seconds or asystole occurring for >3 seconds, with blood pressure rising initially then falling before the heart rate falls 2) Heart rate rising initially then falling to a ventricular rate <40 bpm for >10 seconds or asystole occurring for >3 seconds, with blood pressure rising initially and only falling to hypotensive levels <80 mm Hg systolic at or after the onset of rapid and severe heart rate fall) divided by the number of patients in whom tilt-testing was performed.
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
People with drug-resistant epilepsy whose heart rhythm will be monitored continuously for 2 years using Reveal XT, an implantable heart rate monitor.
Device: implantable heart rate monitor
Implantation of Reveal XT
Other Name: Reveal XT
Please refer to this study by its ClinicalTrials.gov identifier: NCT01946776
|Atrium Medical Center|
|Epilepsy center Kempenhaeghe|
|Epilepsy Instititute in the Netherlands Foundation (SEIN)|
|Hoofddorp, Netherlands, 2130 AM|
|Principal Investigator:||Roland D Thijs, PhD||SEIN-Epilepsy Institute in the Netherlands Foundation|