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Cardiac Rhythm Abnormalities in Patients With Refractory Epilepsy at High Risk for Sudden Death

Cardiac Rhythm Abnormalities in Patients With Refractory Epilepsy at High Risk for Sudden Death

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00203333
Enrollment
19
Registered
2005-09-20
Start date
2002-04-30
Completion date
2010-01-31
Last updated
2016-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmia, Refractory Epilepsy, Sudden Death

Keywords

Epilepsy

Brief summary

People with epilepsy are at a higher risk for sudden unexpected death than the general population. Sudden unexpected death in epilepsy (SUDEP) is a major cause of death in this population, accounting for 10-50% of deaths for those with epilepsy. The risk for SUDEP is particularly high for those with refractory epilepsy. Several lines of evidence support a cardiac mechanism for SUDEP. This study plans to determine: 1. the frequency and types of cardiac arrhythmias that occur in this population and 2. whether these are increased above the general population in the same age group. Additionally, these data will be correlated to specific clinical data, including seizure history, anticonvulsant medications, and any accompanying clinical symptoms.

Detailed description

By employing long-term electrocardiographic monitoring, this study plans to determine: 1. the frequency and types of cardiac arrhythmias that occur in patients with uncontrolled seizures and 2. whether these are increased above the general population in the same age group. The specific aims: 1. Identify the types, frequency, and duration of cardiac arrhythmias that occur in patients with refractory epilepsy and compare these data to available normative data. 2. Correlate abnormal heart rates and rhythms to specific clinical data: 1. seizure type, 2. seizure frequency, 3. probable location of seizure onset in the brain, when such data are available, 4. duration of seizures, and 5. type(s) and number of anticonvulsant medications being used. 3. Correlate cardiac arrhythmias to clinical symptoms

Interventions

DEVICEMedtronic REVEAL

Sponsors

Medtronic
CollaboratorINDUSTRY
Thomas Jefferson University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 49 Years
Healthy volunteers
No

Inclusion criteria

* Refractory epilepsy

Exclusion criteria

* Other pre-existing heart conditions

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026