Cardiac Arrhythmias in Epilepsy: the CARELINK-study

NCT ID: NCT01946776

Last Updated: 2016-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2016-12-31

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).

Conditions

Epilepsy; Asystole; Cardiac Arrhythmias

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Reveal XT

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

Group Type: OTHER

implantable heart rate monitor

Intervention Type: DEVICE

Implantation of Reveal XT

Interventions

implantable heart rate monitor

Implantation of Reveal XT

Intervention Type: DEVICE

Other Intervention Names

Reveal XT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fonds NutsOhra

OTHER

Sponsor Role: collaborator

Medtronic

INDUSTRY

Sponsor Role: collaborator

Stichting Epilepsie Instellingen Nederland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roland D Thijs, PhD

Role: PRINCIPAL_INVESTIGATOR

SEIN-Epilepsy Institute in the Netherlands Foundation

Locations

Atrium Medical Center

Heerlen, , Netherlands

Epilepsy center Kempenhaeghe

Heeze, , Netherlands

Epilepsy Instititute in the Netherlands Foundation (SEIN)

Hoofddorp, , Netherlands

Antonius Hospital

Sneek, , Netherlands

Countries

Netherlands

References

Surges R, Thijs RD, Tan HL, Sander JW. Sudden unexpected death in epilepsy: risk factors and potential pathomechanisms. Nat Rev Neurol. 2009 Sep;5(9):492-504. doi: 10.1038/nrneurol.2009.118. Epub 2009 Aug 11.

Reference Type: BACKGROUND

PMID: 19668244 (View on PubMed)

Schuele SU, Bermeo AC, Alexopoulos AV, Locatelli ER, Burgess RC, Dinner DS, Foldvary-Schaefer N. Video-electrographic and clinical features in patients with ictal asystole. Neurology. 2007 Jul 31;69(5):434-41. doi: 10.1212/01.wnl.0000266595.77885.7f.

Reference Type: BACKGROUND

PMID: 17664402 (View on PubMed)

Rugg-Gunn FJ, Simister RJ, Squirrell M, Holdright DR, Duncan JS. Cardiac arrhythmias in focal epilepsy: a prospective long-term study. Lancet. 2004 Dec 18-31;364(9452):2212-9. doi: 10.1016/S0140-6736(04)17594-6.

Reference Type: BACKGROUND

PMID: 15610808 (View on PubMed)

Nei M, Sperling MR, Mintzer S, Ho RT. Long-term cardiac rhythm and repolarization abnormalities in refractory focal and generalized epilepsy. Epilepsia. 2012 Aug;53(8):e137-40. doi: 10.1111/j.1528-1167.2012.03561.x. Epub 2012 Jun 18.

Reference Type: BACKGROUND

PMID: 22709423 (View on PubMed)

Sevcencu C, Struijk JJ. Autonomic alterations and cardiac changes in epilepsy. Epilepsia. 2010 May;51(5):725-37. doi: 10.1111/j.1528-1167.2009.02479.x. Epub 2010 Jan 7.

Reference Type: BACKGROUND

PMID: 20067509 (View on PubMed)

Other Identifiers

1201-071

Identifier Type: -

Identifier Source: org_study_id