Reveal LINQ ICM System for Lennox Gastaut Syndrome (LOOP Trial)

N/A

Waitlist Available

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during the two years of monitoring

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at heart problems in people with different types of epilepsy. It aims to find out if special heart medications or devices can help prevent serious heart issues and make seizures less severe.

Eligible Conditions

Lennox Gastaut Syndrome
Epilepsy
Epileptic Encephalopathy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the two years of monitoring

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during the two years of monitoring

This trial's timeline: 3 weeks for screening, Varies for treatment, and during the two years of monitoring for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence rate of an event (i.e., arrhythmia or seizure)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: LINQ ICMExperimental Treatment1 Intervention

The LINQ ICM (Medtronic, Inc.) is a small FDA approved cardiac monitor implanted in the subcutaneous tissue of the chest wall that is designed to continuously record a single-lead ECG, monitoring the cardiac rhythm for up to three years. The device records and stores patient's rhythm on two occasions: first when programmed criteria are met and second upon patient activation. These programmable arrhythmia criteria are based on heart rate (bradycardia, tachycardia), irregularity of heart rate and duration of rate disturbance. The LINQ ICM (or future iterations) will be utilized in this study to detect arrhythmias in our study population. The LINQ ICM is approved by the FDA for use in patients where there is a suspicion of occult cardiac arrhythmias and is therefore being utilized in this study in accordance with the FDA labeling.

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