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Cardiac Monitoring Device

Reveal LINQ ICM System for Epilepsy (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

LOOP Trial Summary

This study is evaluating whether individuals with epilepsy have a higher risk for cardiac complications.

Eligible Conditions
  • Epileptic Encephalopathy
  • Epilepsy
  • Lennox Gastaut Syndrome

LOOP Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence rate of an event (i.e., arrhythmia or seizure)

LOOP 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.

Find a Location

Who is running the clinical trial?

MedtronicIndustry Sponsor
605 Previous Clinical Trials
828,188 Total Patients Enrolled
6 Trials studying Epilepsy
108 Patients Enrolled for Epilepsy
Northwell HealthLead Sponsor
458 Previous Clinical Trials
470,926 Total Patients Enrolled
7 Trials studying Epilepsy
888 Patients Enrolled for Epilepsy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Long-term Cardiac Monitoring in Epilepsy
Ruben Kuzniecky 2019. "Long-term Cardiac Monitoring in Epilepsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03955432.
~1 spots leftby Apr 2025
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