Cardiac Arrhythmias in Epilepsy: the CARELINK-study

Not Applicable

Completed

• Conditions: Cardiac Arrhythmias; Epilepsy; Asystole
• Interventions: Device: implantable heart rate monitor

• Registration Number: NCT01946776
• Lead Sponsor: Stichting Epilepsie Instellingen Nederland

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-08-29
• Study First Submitted QC: 2013-09-16
• Study First Posted: 2013-09-20
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-23
• Last Update Posted: 2016-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Reveal XT	implantable heart rate monitor	People with drug-resistant epilepsy whose heart rhythm will be monitored continuously for 2 years using Reveal XT, an implantable heart rate monitor.

Primary Outcome Measures

Name	Time	Method
Incidence and two-year prevalence of clinically relevant cardiac arrhythmia.	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)	Clinical relevant cardiac arrhythmia is defined as: 1. 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.; 2. Asystole of ≥10s regardless of report of clinical symptoms; 3. Other cardiac arrhythmias of clinical significance: 1. polymorphic sustained or non-sustained ventricular tachycardia (VT); 2. non-sustained monomorphic VT of \>180 bpm and \>2s duration, or \>175 bpm and \>3s duration, and sustained monomorphic VT; 3. atrial fibrillation (AF) of \>200 bpm and \>30s duration, or \<55 bpm and clinical symptoms (dizziness or dyspnea); 4. persistent sinus bradycardia of \<40 bpm during physical activity; 5. asymptomatic 2nd or 3rd degree atrioventricular (AV) block of \>4s duration

Secondary Outcome Measures

Name	Time	Method
the number of patients who will have received a permanent pacemaker at the end of this study.	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)	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.

Trial Locations

Locations (4)

Atrium Medical Center; 🇳🇱 Heerlen, Netherlands

Epilepsy center Kempenhaeghe; 🇳🇱 Heeze, Netherlands

Antonius Hospital; 🇳🇱 Sneek, Netherlands

Epilepsy Instititute in the Netherlands Foundation (SEIN); 🇳🇱 Hoofddorp, Netherlands