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| Name | Class |
|---|---|
| Fonds NutsOhra | OTHER |
| Medtronic | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reveal XT | Other | People with drug-resistant epilepsy whose heart rhythm will be monitored continuously for 2 years using Reveal XT, an implantable heart rate monitor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| implantable heart rate monitor | Device | Implantation of Reveal XT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and two-year prevalence of clinically relevant cardiac arrhythmia. | Clinical relevant cardiac arrhythmia is defined as:
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| the number of patients who will have received a permanent pacemaker at the end of this study. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of seizure-related cardiac arrhythmias | The number of seizures during which a cardiac arrhythmia occurs divided by the total number of seizures during 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roland D Thijs, PhD | SEIN-Epilepsy Institute in the Netherlands Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Medical Center | Heerlen | Netherlands | ||||
| Epilepsy center Kempenhaeghe |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19668244 | Background | 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. | |
| 17664402 | Background | 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. |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D006323 | Heart Arrest |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006331 | Heart Diseases |
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| 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) |
| The percentage of patients with a cardioinhibitory response to head-up tilt-testing |
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. |
| During one head-up tilt-test (approximate duration 1,5 hours) |
| Heeze |
| Netherlands |
| Epilepsy Instititute in the Netherlands Foundation (SEIN) | Hoofddorp | 2130 AM | Netherlands |
| Antonius Hospital | Sneek | Netherlands |
| 15610808 | Background | 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. |
| 22709423 | Background | 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. |
| 20067509 | Background | 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. |
| D002318 |
| Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |